Trial Outcomes & Findings for Next Generation ORS: Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea (NCT NCT05814042)
NCT ID: NCT05814042
Last Updated: 2026-04-14
Results Overview
Daily stool output was defined as the total weight of all stools (g) passed during a given 24-hour intervention day. Total stool output was defined as the cumulative weight of all stools (g) passed over the entire 72-hour study period or until diarrhea resolved, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
396 participants
Primary outcome timeframe
Day 1, day 2, Day 3, and entire 3 days
Results posted on
2026-04-14
Participant Flow
Over a period of 18-24 months, we recruit: Severely dehydrated 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera (n=30/group x 2 groups) (Aim 1). In parallel, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration (n=167/group and 169/group; 2 groups), a total of 336 patients. (Aim 2).
Work Flow: Triage =\>ER/SSU: Step 1: Verbal Consent, Study Nurse (SN)/ Field Research Supervisor (FRS) put a tag on bed and write screening ID on top of Study CRF=\>Study Ward/Allocated Space: Step 2: HW Screening Form; Step 3: FRS if enrollment criteria met consent done; Step 4: SN Complete admission section of CRF including clinical signs of dehydration; Step 5: Randomization to 72h or till diarrhea cease=\> Discharge Step-6: SN/PRP record outcome; Step 7: FRS Follow up at enrollment day 7.
Participant milestones
| Measure |
ORS With Calcium (Aim 1)
30 severely dehydrated adult patients infected with V. Cholerae (Rapid diagnostic test (RDT+) (Aim 1) were randomized to receive ORS with calcium (intervention) in hospital for 72 hours or up to the time when the patients fulfil the criteria of cessation of diarrhea.
|
Standard WHO Oral Rehydration Solution (ORS; Aim 1)
30 severely dehydrated adult patients infected with V. Cholerae (Rapid diagnostic test (RDT+) (Aim 1) were randomized to Standard WHO ORS without calcium (Control) in hospital for 72 hours or up to the time when the patients fulfil the criteria of cessation of diarrhea.
|
ORS With Calcium (Aim 2)
167 adults with non-bloody, non-cholera acute diarrhea with Some dehydration (Aim 2) were randomized to receive ORS with calcium (intervention) in hospital for 72 hours or up to the time when the patients fulfil the criteria of cessation of diarrhea.
|
Standard WHO Oral Rehydration Solution (ORS; Aim 2)
169 adults with non-bloody, non-cholera acute diarrhea with Some dehydration (Aim 2) were randomized to Standard WHO ORS without calcium (Control) in hospital for 72 hours or up to the time when the patients fulfil the criteria of cessation of diarrhea.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
167
|
169
|
|
Overall Study
COMPLETED
|
30
|
30
|
167
|
169
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
Baseline characteristics by cohort
| Measure |
ORS With Calcium: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS With Calcium: Aim 2
n=167 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
ORS: Aim 2
n=169 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 10.8 • n=30 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
31.0 years
STANDARD_DEVIATION 10.5 • n=30 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
34.0 years
STANDARD_DEVIATION 9.8 • n=167 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
33.9 years
STANDARD_DEVIATION 9.7 • n=169 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
33.6 years
STANDARD_DEVIATION 10.1 • n=396 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
|
Sex: Female, Male
Female
|
3 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
67 Participants
n=167 Participants
|
65 Participants
n=169 Participants
|
139 Participants
n=396 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=30 Participants
|
26 Participants
n=30 Participants
|
100 Participants
n=167 Participants
|
104 Participants
n=169 Participants
|
257 Participants
n=396 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
52.1 kilogram
STANDARD_DEVIATION 11.3 • n=30 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
49.2 kilogram
STANDARD_DEVIATION 12.0 • n=30 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
53.3 kilogram
STANDARD_DEVIATION 10.1 • n=167 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
54.4 kilogram
STANDARD_DEVIATION 10.4 • n=169 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
53.4 kilogram
STANDARD_DEVIATION 12.3 • n=396 Participants • Due to randomization, the actual number of participants in the two groups of Aim 2 are slightly different, ie, 167 vs 169 instead of 168 vs 168
|
|
Correction by IV fluid (ml)
|
5550 ml
STANDARD_DEVIATION 1053 • n=30 Participants
|
5467 ml
STANDARD_DEVIATION 776 • n=30 Participants
|
591 ml
STANDARD_DEVIATION 831 • n=167 Participants
|
250 ml
STANDARD_DEVIATION 707 • n=169 Participants
|
1191 ml
STANDARD_DEVIATION 1892 • n=396 Participants
|
PRIMARY outcome
Timeframe: Day 1, day 2, Day 3, and entire 3 daysPopulation: The number analyzed in individual rows differs from the overall sample size because diarrhea resolved over time.
Daily stool output was defined as the total weight of all stools (g) passed during a given 24-hour intervention day. Total stool output was defined as the cumulative weight of all stools (g) passed over the entire 72-hour study period or until diarrhea resolved, whichever occurred first.
Outcome measures
| Measure |
ORS With Calcium: Aim 2 (Severe Diarrhea Subset)
n=32 Participants
This Group is a subset of the ORS with calcium: Aim 2 group (32 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Severe Diarrhea Subset)
n=32 Participants
This Group is a subset of the ORS: Aim 2 group (32 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 2 (Non-Severe Diarrhea Subset)
n=135 Participants
This Group is a subset of the ORS with calcium: Aim 2 group (135 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Non-Severe Diarrhea Subset)
n=137 Participants
This Group is a subset of the ORS: Aim 2 group (137 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS With Calcium: Aim 2
n=167 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
ORS: Aim 2
n=169 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
|---|---|---|---|---|---|---|---|---|
|
Stool Output
Day 1 Stool Output
|
4242 gram
Standard Deviation 2270
|
5008 gram
Standard Deviation 2494
|
987 gram
Standard Deviation 803
|
812 gram
Standard Deviation 740
|
4769 gram
Standard Deviation 1989
|
4742 gram
Standard Deviation 2165
|
1688 gram
Standard Deviation 1842
|
1704 gram
Standard Deviation 2167
|
|
Stool Output
Total stool output
|
4242 gram
Standard Deviation 2270
|
5008 gram
Standard Deviation 2494
|
987 gram
Standard Deviation 803
|
812 gram
Standard Deviation 740
|
5412 gram
Standard Deviation 2945
|
5581 gram
Standard Deviation 3046
|
2308 gram
Standard Deviation 3460
|
2576 gram
Standard Deviation 4127
|
|
Stool Output
Day 2 Stool Output
|
—
|
—
|
—
|
—
|
638 gram
Standard Deviation 1116
|
768 gram
Standard Deviation 996
|
1326 gram
Standard Deviation 1946
|
1601 gram
Standard Deviation 2182
|
|
Stool Output
Day 3 Stool Output
|
—
|
—
|
—
|
—
|
485 gram
Standard Deviation 629
|
360 gram
Standard Deviation 356
|
1156 gram
Standard Deviation 1840
|
2004 gram
Standard Deviation 1604
|
SECONDARY outcome
Timeframe: from randomization to end of treatment at day 3Duration of diarrhea was the time (in hour) from randomization until cessation of diarrhea
Outcome measures
| Measure |
ORS With Calcium: Aim 2 (Severe Diarrhea Subset)
This Group is a subset of the ORS with calcium: Aim 2 group (32 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Severe Diarrhea Subset)
This Group is a subset of the ORS: Aim 2 group (32 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 2 (Non-Severe Diarrhea Subset)
This Group is a subset of the ORS with calcium: Aim 2 group (135 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Non-Severe Diarrhea Subset)
This Group is a subset of the ORS: Aim 2 group (137 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS With Calcium: Aim 2
n=167 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
ORS: Aim 2
n=169 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
|---|---|---|---|---|---|---|---|---|
|
Duration of Diarrhea
|
—
|
—
|
—
|
—
|
24.75 hours
Standard Deviation 9.50
|
25.80 hours
Standard Deviation 13.00
|
14.6 hours
Standard Deviation 16.8
|
16.4 hours
Standard Deviation 20.3
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3Population: The number analyzed in individual rows differs from the overall sample size because diarrhea resolved over time.
Daily stool frequency was defined as the total number of diarrhea stools passed during a given 24-hour intervention day.
Outcome measures
| Measure |
ORS With Calcium: Aim 2 (Severe Diarrhea Subset)
n=32 Participants
This Group is a subset of the ORS with calcium: Aim 2 group (32 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Severe Diarrhea Subset)
n=32 Participants
This Group is a subset of the ORS: Aim 2 group (32 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 2 (Non-Severe Diarrhea Subset)
n=135 Participants
This Group is a subset of the ORS with calcium: Aim 2 group (135 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Non-Severe Diarrhea Subset)
n=137 Participants
This Group is a subset of the ORS: Aim 2 group (137 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS With Calcium: Aim 2
n=167 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
ORS: Aim 2
n=169 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
|---|---|---|---|---|---|---|---|---|
|
Stool Frequency
Stool frequency: Day 1
|
16.5 Events
Standard Deviation 9.2
|
21.4 Events
Standard Deviation 11.8
|
6.7 Events
Standard Deviation 5.1
|
5.9 Events
Standard Deviation 4.2
|
21.4 Events
Standard Deviation 9.3
|
19.0 Events
Standard Deviation 8.3
|
8.8 Events
Standard Deviation 7.4
|
9.2 Events
Standard Deviation 9.2
|
|
Stool Frequency
Stool frequency: Day 2
|
—
|
—
|
—
|
—
|
3.6 Events
Standard Deviation 3.9
|
4.2 Events
Standard Deviation 4.7
|
5.9 Events
Standard Deviation 6.1
|
7.5 Events
Standard Deviation 8.1
|
|
Stool Frequency
Stool frequency: Day 3
|
—
|
—
|
—
|
—
|
5 Events
Standard Deviation 5
|
2.5 Events
Standard Deviation 2.4
|
5.5 Events
Standard Deviation 7.1
|
9.3 Events
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3Population: The number analyzed in individual rows differs from the overall sample size because the number of patients who vomited varies from day to day.
Daily volume of vomiting was defined as the total weight of all vomitus (g) during a given 24-hour intervention day.
Outcome measures
| Measure |
ORS With Calcium: Aim 2 (Severe Diarrhea Subset)
This Group is a subset of the ORS with calcium: Aim 2 group (32 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Severe Diarrhea Subset)
This Group is a subset of the ORS: Aim 2 group (32 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 2 (Non-Severe Diarrhea Subset)
This Group is a subset of the ORS with calcium: Aim 2 group (135 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Non-Severe Diarrhea Subset)
This Group is a subset of the ORS: Aim 2 group (137 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS With Calcium: Aim 2
n=167 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
ORS: Aim 2
n=169 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
|---|---|---|---|---|---|---|---|---|
|
Vomiting
Vomiting: Day 2
|
—
|
—
|
—
|
—
|
27.7 gram
Standard Deviation 151.5
|
43.3 gram
Standard Deviation 188.9
|
58.6 gram
Standard Deviation 227.9
|
257.2 gram
Standard Deviation 608.1
|
|
Vomiting
Vomiting: Day 3
|
—
|
—
|
—
|
—
|
—
|
—
|
221.0 gram
Standard Deviation 454.4
|
171.8 gram
Standard Deviation 347.8
|
|
Vomiting
Vomiting: Day 1
|
—
|
—
|
—
|
—
|
313.5 gram
Standard Deviation 495
|
283 gram
Standard Deviation 459
|
111.4 gram
Standard Deviation 311
|
136 gram
Standard Deviation 399
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3Population: Overall might be all participants, while rows are specific treatment arms, some potentially smaller.
Percentage of patients who require unscheduled intravenous therapy at Day1, Day 2 and Day 3 following intervention.
Outcome measures
| Measure |
ORS With Calcium: Aim 2 (Severe Diarrhea Subset)
This Group is a subset of the ORS with calcium: Aim 2 group (32 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Severe Diarrhea Subset)
This Group is a subset of the ORS: Aim 2 group (32 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 2 (Non-Severe Diarrhea Subset)
This Group is a subset of the ORS with calcium: Aim 2 group (135 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Non-Severe Diarrhea Subset)
This Group is a subset of the ORS: Aim 2 group (137 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS With Calcium: Aim 2
n=167 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
ORS: Aim 2
n=169 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Require Unscheduled Intravenous Therapy
Percentage of patients who require unscheduled intravenous therapy: Day 1
|
—
|
—
|
—
|
—
|
4 Participants
|
4 Participants
|
6 Participants
|
8 Participants
|
|
Percentage of Patients Who Require Unscheduled Intravenous Therapy
Percentage of patients who require unscheduled intravenous therapy: Day 2
|
—
|
—
|
—
|
—
|
1 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
|
Percentage of Patients Who Require Unscheduled Intravenous Therapy
Percentage of patients who require unscheduled intravenous therapy: Day 3
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1, Day 2, Day 3Population: The number analyzed in individual rows differs from the overall sample size because diarrhea resolved over time.
Intake of ORS (ml) from randomization until cessation of diarrhea in Day 1, Day2, and Day 3.
Outcome measures
| Measure |
ORS With Calcium: Aim 2 (Severe Diarrhea Subset)
This Group is a subset of the ORS with calcium: Aim 2 group (32 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Severe Diarrhea Subset)
This Group is a subset of the ORS: Aim 2 group (32 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 2 (Non-Severe Diarrhea Subset)
This Group is a subset of the ORS with calcium: Aim 2 group (135 out of 167). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS: Aim 2 (Non-Severe Diarrhea Subset)
This Group is a subset of the ORS: Aim 2 group (137 out of 169). Unlike Aim 1, which enrolled a small cohort of 60 cholera patients with severe dehydration, Aim 2 randomized 336 non-cholera patients with some dehydration. Although all participants met WHO criteria for some dehydration, disease severity varied substantially. Stool output ranged widely, with some patients demonstrating very high outputs (e.g., \>1,500 mL in the first 8 hours of Day 1), while others had more modest losses.
To evaluate whether diarrhea severity influenced treatment outcomes, we performed a stratified analysis within Aim 2 based on diarrhea severity. Severe diarrhea was defined as stool weight ≥1,500 g during the first 8 hours of Day 1 or stool weight ≥50 g/kg/day on Day 1. Non-severe diarrhea was defined as stool weight \<1,500 g during the first 8 hours of Day 1 or stool weight \<50 g/kg/day on Day 1.
|
ORS With Calcium: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS: Aim 1
n=30 Participants
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated "ORS: Aim 1"; n=30) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 1"; n=30).
|
ORS With Calcium: Aim 2
n=167 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
ORS: Aim 2
n=169 Participants
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated "ORS: Aim 2"; n=169) or Standard WHO ORS with 10 mM calcium citrate (designated "ORS with calcium: Aim 2; n=167), a total of 336 patients in Aim 2.
|
|---|---|---|---|---|---|---|---|---|
|
Intake of ORS
Intake of ORS: Day 1
|
—
|
—
|
—
|
—
|
5107 ml
Standard Deviation 1616
|
5105 ml
Standard Deviation 2064
|
2992 ml
Standard Deviation 1786
|
3145 ml
Standard Deviation 2004
|
|
Intake of ORS
Intake of ORS: Day 2
|
—
|
—
|
—
|
—
|
1075 ml
Standard Deviation 1147
|
1458 ml
Standard Deviation 1471
|
2016 ml
Standard Deviation 1680
|
2451 ml
Standard Deviation 1890
|
|
Intake of ORS
Intake of ORS: Day 3
|
—
|
—
|
—
|
—
|
3250 ml
Standard Deviation 1117
|
750 ml
Standard Deviation 1173
|
1250 ml
Standard Deviation 1372
|
3300 ml
Standard Deviation 1951
|
Adverse Events
ORS With Calcium: Aim 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ORS: Aim 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ORS With Calcium: Aim 2
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
ORS: Aim 2
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ORS With Calcium: Aim 1
n=30 participants at risk
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated ORS) or Standard WHO ORS with 10 mM calcium citrate (designated ORS with calcium) (n=30/group x 2 groups).
|
ORS: Aim 1
n=30 participants at risk
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated ORS) or Standard WHO ORS with 10 mM calcium citrate (designated ORS with calcium) (n=30/group x 2 groups).
|
ORS With Calcium: Aim 2
n=167 participants at risk
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated ORS) or Standard WHO ORS with 10 mM calcium citrate (designated ORS with calcium) (n=168/group x 2 groups), a total of 336 patients.
|
ORS: Aim 2
n=169 participants at risk
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated as ORS) or Standard WHO ORS with 10 mM calcium citrate (designated as ORS with calcium) (n=168/group x 2 groups), a total of 336 patients.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Hypovolemic shock
|
0.00%
0/30 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
0.00%
0/30 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
0.60%
1/167 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
0.59%
1/169 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
Other adverse events
| Measure |
ORS With Calcium: Aim 1
n=30 participants at risk
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated ORS) or Standard WHO ORS with 10 mM calcium citrate (designated ORS with calcium) (n=30/group x 2 groups).
|
ORS: Aim 1
n=30 participants at risk
In Aim 1, severely dehydrated ('Severe' dehydration) 60 adult patients (≥18 to ≤60 yrs), duration \<24hrs, with cholera were randomized to receive Standard WHO ORS (designated ORS) or Standard WHO ORS with 10 mM calcium citrate (designated ORS with calcium) (n=30/group x 2 groups).
|
ORS With Calcium: Aim 2
n=167 participants at risk
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated ORS) or Standard WHO ORS with 10 mM calcium citrate (designated ORS with calcium) (n=168/group x 2 groups), a total of 336 patients.
|
ORS: Aim 2
n=169 participants at risk
In parallel, in Aim 2, adults ((≥18 to ≤60 yrs) with non-V. cholera (RDT/cholkit dipstick negative) non-bloody acute diarrhea with 'Some' dehydration were randomized to receive Standard WHO ORS (designated as ORS) or Standard WHO ORS with 10 mM calcium citrate (designated as ORS with calcium) (n=168/group x 2 groups), a total of 336 patients.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
fever
|
0.00%
0/30 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
0.00%
0/30 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
6.6%
11/167 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
4.1%
7/169 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
|
Gastrointestinal disorders
Epigastric pain
|
0.00%
0/30 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
0.00%
0/30 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
1.2%
2/167 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
0.59%
1/169 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/30 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
0.00%
0/30 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
0.60%
1/167 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
|
1.8%
3/169 • from randomization until cessation of diarrhea, up to three days. Cessation of diarrhea will be defined as the last watery or loose stool before passage of two consecutive soft or formed stools, or the beginning of 8 consecutive hours without any stool.
Adverse Event (AE): Any untoward medical occurrence in a subject administered an assigned ORS that does not necessarily have causal relationships with the treatment such as fever, epigastric pain or heartburn that is temporarily associated with the use of the ORS, whether or not considered related to the ORS. Serious Adverse Event (SAE): Any AE that results in death, is life-threatening, requires hospitalization, or results in persistent or significant disability such as hypovolemic shock.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place