Trial Outcomes & Findings for Cholecalciferol Supplementation for Sepsis in the ICU (NCT NCT01896544)
NCT ID: NCT01896544
Last Updated: 2016-06-13
Results Overview
Subjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Vitamin D status at the onset of a suspected case of sepsis will be compared to vitamin D status between 5-9 days after supplementation with cholecalciferol or placebo. To assess vitamin D status, we will measure serum and urine: 1) 25-hydroxyvitamin D; 2) 1,25-dihydroxyvitamin D; 3) 24,25-dihydroxyvitamin D; 4) Fibroblast growth factor 23; 5) Vitamin D binding protein; 6) LL-37; 7) Parathyroid hormone; 8) Albumin; 9) Calcium; and 10) Phosphorus levels.
COMPLETED
PHASE3
30 participants
Patients will be followed between the onset of suspected sepsis and for an average duration of 7 days
2016-06-13
Participant Flow
Participant milestones
| Measure |
Placebo
Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose I
Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose II
Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cholecalciferol Supplementation for Sepsis in the ICU
Baseline characteristics by cohort
| Measure |
Cholecalciferol Dose II
n=10 Participants
Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
Placebo
n=10 Participants
Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose I
n=10 Participants
Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
65 years
n=107 Participants
|
64 years
n=206 Participants
|
64 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
30 participants
n=7 Participants
|
|
Body mass index
|
30 kg/m^2
n=99 Participants
|
28 kg/m^2
n=107 Participants
|
28 kg/m^2
n=206 Participants
|
28 kg/m^2
n=7 Participants
|
|
Acute Physiology and Chronic Health Evaluation II (APACHE II) score
|
23 scores on a scale
n=99 Participants
|
22 scores on a scale
n=107 Participants
|
21 scores on a scale
n=206 Participants
|
22 scores on a scale
n=7 Participants
|
|
Intensive Care Unit (ICU) type
medical
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
16 participants
n=7 Participants
|
|
Intensive Care Unit (ICU) type
surgical
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
14 participants
n=7 Participants
|
|
Positive culture
Pulmonary
|
40 percentage
n=99 Participants
|
40 percentage
n=107 Participants
|
50 percentage
n=206 Participants
|
130 percentage
n=7 Participants
|
|
Positive culture
Blood stream
|
70 percentage
n=99 Participants
|
60 percentage
n=107 Participants
|
60 percentage
n=206 Participants
|
190 percentage
n=7 Participants
|
|
Positive culture
Urinary
|
10 percentage
n=99 Participants
|
10 percentage
n=107 Participants
|
10 percentage
n=206 Participants
|
30 percentage
n=7 Participants
|
|
Day 1 data: 25 hydroxyvitaminD(25OHD),bioavailable 25 hydroxyvitamin D(B25OHD), cathelicidin (LL-37)
Day 1 25OHD (ng/mL)
|
17 ng/mL
n=99 Participants
|
19 ng/mL
n=107 Participants
|
15 ng/mL
n=206 Participants
|
17 ng/mL
n=7 Participants
|
|
Day 1 data: 25 hydroxyvitaminD(25OHD),bioavailable 25 hydroxyvitamin D(B25OHD), cathelicidin (LL-37)
Day 1 B25OHD (ng/mL)
|
2.5 ng/mL
n=99 Participants
|
1.4 ng/mL
n=107 Participants
|
1.9 ng/mL
n=206 Participants
|
1.9 ng/mL
n=7 Participants
|
|
Day 1 data: 25 hydroxyvitaminD(25OHD),bioavailable 25 hydroxyvitamin D(B25OHD), cathelicidin (LL-37)
Day 1 LL-37 (ng/mL)
|
51 ng/mL
n=99 Participants
|
53 ng/mL
n=107 Participants
|
52 ng/mL
n=206 Participants
|
52 ng/mL
n=7 Participants
|
|
30 day readmission
No
|
10 participants
n=99 Participants
|
8 participants
n=107 Participants
|
10 participants
n=206 Participants
|
28 participants
n=7 Participants
|
|
30 day readmission
Yes
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
2 participants
n=7 Participants
|
|
30 day mortality
dead
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
30 day mortality
alive
|
8 participants
n=99 Participants
|
7 participants
n=107 Participants
|
7 participants
n=206 Participants
|
22 participants
n=7 Participants
|
|
Day 1 data: high-sensitivity c-reactive protein (hs-CRP)
|
119 mg/L
n=99 Participants
|
106 mg/L
n=107 Participants
|
208 mg/L
n=206 Participants
|
119 mg/L
n=7 Participants
|
|
Day 1: total body fluid balance (TBB)
|
1,518 mL
n=99 Participants
|
1592 mL
n=107 Participants
|
1,730 mL
n=206 Participants
|
1,592 mL
n=7 Participants
|
PRIMARY outcome
Timeframe: Patients will be followed between the onset of suspected sepsis and for an average duration of 7 daysSubjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Vitamin D status at the onset of a suspected case of sepsis will be compared to vitamin D status between 5-9 days after supplementation with cholecalciferol or placebo. To assess vitamin D status, we will measure serum and urine: 1) 25-hydroxyvitamin D; 2) 1,25-dihydroxyvitamin D; 3) 24,25-dihydroxyvitamin D; 4) Fibroblast growth factor 23; 5) Vitamin D binding protein; 6) LL-37; 7) Parathyroid hormone; 8) Albumin; 9) Calcium; and 10) Phosphorus levels.
Outcome measures
| Measure |
Placebo
n=10 Participants
Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose I
n=10 Participants
Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose II
n=10 Participants
Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
|---|---|---|---|
|
Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol
Day 1
|
19 ng/mL
Interval 13.0 to 22.0
|
15 ng/mL
Interval 12.0 to 20.0
|
17 ng/mL
Interval 13.0 to 25.0
|
|
Change in Vitamin D Status 5 Days Following Supplementation With Cholecalciferol
Day 5
|
19 ng/mL
Interval 11.0 to 23.0
|
22 ng/mL
Interval 16.0 to 25.0
|
29 ng/mL
Interval 23.0 to 41.0
|
SECONDARY outcome
Timeframe: Patients will be followed between the onset of suspected sepsis and for an average duration of 7 daysSubjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum LL-37.
Outcome measures
| Measure |
Placebo
n=10 Participants
Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose I
n=10 Participants
Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose II
n=10 Participants
Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
|---|---|---|---|
|
Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol
Day 1 LL-37 (ng/mL)
|
53 ng/mL
Interval 43.0 to 62.0
|
52 ng/mL
Interval 48.0 to 59.0
|
51 ng/mL
Interval 41.0 to 52.0
|
|
Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol
Day 5 LL 37 (ng/mL)
|
50 ng/mL
Interval 35.0 to 54.0
|
54 ng/mL
Interval 40.0 to 64.0
|
67 ng/mL
Interval 59.0 to 68.0
|
SECONDARY outcome
Timeframe: Patients will be followed between the onset of suspected sepsis and for an average duration of 90 daysSubjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of: 1) ICU length of stay; and 2) hospital length of stay
Outcome measures
| Measure |
Placebo
n=10 Participants
Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose I
n=10 Participants
Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose II
n=10 Participants
Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
|---|---|---|---|
|
Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis
ICU length of stay
|
12 days
Interval 7.0 to 15.0
|
4 days
Interval 3.0 to 11.0
|
3 days
Interval 2.0 to 11.0
|
|
Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis
Hospital length of stay
|
21 days
Interval 18.0 to 31.0
|
13 days
Interval 12.0 to 16.0
|
14 days
Interval 8.0 to 21.0
|
SECONDARY outcome
Timeframe: Patients will be followed between the onset of suspected sepsis and for an average duration of 90 daysSubjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. The incidence of infection-related complications will be assessed between the onset of suspected sepsis and 80-100 days after supplementation with cholecalciferol or placebo. To assess the incidence of infection-related complications, we will measure rates of: 1\) 30 day hospital readmission; and 2) 30 day mortality.
Outcome measures
| Measure |
Placebo
n=10 Participants
Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose I
n=10 Participants
Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose II
n=10 Participants
Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
|---|---|---|---|
|
Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis
30 day readmission: no
|
8 participants
|
10 participants
|
10 participants
|
|
Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis
30 day readmission: yes
|
2 participants
|
0 participants
|
0 participants
|
|
Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis
30 day mortality: dead
|
3 participants
|
3 participants
|
2 participants
|
|
Incidence of Infection-related Complications Within 90 Days From the Onset of a Suspected Case of Sepsis
30 day mortality:alive
|
7 participants
|
7 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Patients will be followed between the onset of suspected sepsis and for an average duration of 90 daysSubjects will receive 200,000 IU or 400,000 IU cholecalciferol suspension (vs. placebo) within 24 hours from the onset of a suspected case of sepsis during their hospitalization. Immunological profile at the onset of a suspected case of sepsis will be compared to the immunological profile between 5-9 days after supplementation with cholecalciferol or placebo. To assess the immunological profile, we will measure serum hsCRP.
Outcome measures
| Measure |
Placebo
n=10 Participants
Oral suspension of placebo cholecalciferol
Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose I
n=10 Participants
Oral suspension cholecalciferol 200,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
Cholecalciferol Dose II
n=10 Participants
Oral suspension cholecalciferol 400,000 IU
Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube
|
|---|---|---|---|
|
Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol
Day 1 hsCRP (mg/L)
|
106 mg/L
Interval 60.0 to 267.0
|
208 mg/L
Interval 90.0 to 369.0
|
119 mg/L
Interval 85.0 to 247.0
|
|
Change in Immunological Profile 5 Days Following Supplementation With Cholecalciferol
D 5 hsCRP (mg/L)
|
53 mg/L
Interval 38.0 to 72.0
|
98 mg/L
Interval 12.0 to 130.0
|
31 mg/L
Interval 26.0 to 160.0
|
Adverse Events
Placebo
Cholecalciferol Dose I
Cholecalciferol Dose II
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place