Trial Outcomes & Findings for Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day (NCT NCT03645785)
NCT ID: NCT03645785
Last Updated: 2021-02-21
Results Overview
Citrate/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation
COMPLETED
NA
23 participants
Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm)
2021-02-21
Participant Flow
Study participants were recruited from Albany Medical Center Urology clinic. A total of 23 participants were recruited
23 patients were enrolled, but 3 had to be excluded based on study exclusion criteria. 3 patients had a history of nephrolithiasis.
Participant milestones
| Measure |
Non-Stone Forming
All 23 patients completed both interventions, and were used as their own control for baseline vs increased fluid/citrate intake comparisons in this cross over study.
The same cohort underwent the following 2 periods, and all participants competed both
Period 1: Normal drinking habits and diet. This was for a total of 24 hours (i.e. Day 1). Urine was collected throughout day 1
Period 2: Increased fluid intake and citrate supplement (I.e. day 2-4). Participants all were encouraged to double their baseline fluid intake compared to day 1, and drink 1 bottle of Poland Spring 16.9oz with 1 packet of True lemon per day. Urine was collected throughout day 4.
|
|---|---|
|
Day 1 (Normal Fluid Intake and Diet)
STARTED
|
23
|
|
Day 1 (Normal Fluid Intake and Diet)
COMPLETED
|
23
|
|
Day 1 (Normal Fluid Intake and Diet)
NOT COMPLETED
|
0
|
|
Day 2-4 (Double Fluid and Add Citrate)
STARTED
|
23
|
|
Day 2-4 (Double Fluid and Add Citrate)
COMPLETED
|
23
|
|
Day 2-4 (Double Fluid and Add Citrate)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non-Stone Forming Cohort
n=20 Participants
All 23 patients completed both interventions, and were used as their own control for baseline vs increased fluid/citrate intake comparisons in this cross over study.
The same cohort underwent the following 2 periods, and all participants competed both
Period 1: Normal drinking habits and diet. This was for a total of 24 hours (i.e. Day 1). Urine was collected throughout day 1
Period 2: Increased fluid intake and citrate supplement (I.e. day 2-4). Participants all were encouraged to double their baseline fluid intake compared to day 1, and drink 1 bottle of Poland Spring 16.9oz with 1 packet of True lemon per day. Urine was collected throughout day 4.
|
|---|---|
|
Age, Customized
Age >/= 18
|
20 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
|
BMI
|
25.9 kg/m^2
n=20 Participants
|
|
Use of Vitamins
|
8 Participants
n=20 Participants
|
|
Diet
Vegetarians
|
2 Participants
n=20 Participants
|
|
Diet
Clean
|
1 Participants
n=20 Participants
|
|
Diet
Gluten Free
|
1 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm)Population: Each participant had urine collected at each time listed: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm). Data was collected on the Citrate/Creatinine Ratio at each time period void. Thus, at each time of day, there was an N equivalent to the number of voids across all entire 20 participant cohort. Since it was the same participant providing the void at the different times, the sum of participants does not add to the n in the study population (20).
Citrate/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation
Outcome measures
| Measure |
5pm Void Post
n=19 Participants
increased fluid intake cohort 5p.m void
|
5p.m. Pre
n=20 Participants
normal fluid intake 5 p.m void
|
1-2 pm Post
n=19 Participants
void time post intervention
|
1-2pm Void Pre
n=20 Participants
void time pre intervention
|
9-10AM Post
n=20 Participants
void time post intervention
|
9-10AM Pre
n=20 Participants
void time pre intervention
|
First Void Pre
n=20 Participants
pre intervention, first void
|
First Void Post
n=20 Participants
post intervention post void
|
|---|---|---|---|---|---|---|---|---|
|
Citrate/Creatinine Ratio
|
0.658644 ratio
Standard Deviation 0.429258801
|
0.584115 ratio
Standard Deviation 0.393029128
|
0.562886 ratio
Standard Deviation 0.309518524
|
0.540394 ratio
Standard Deviation 0.332082046
|
0.490685 ratio
Standard Deviation 0.246362039
|
0.441938 ratio
Standard Deviation 0.209042617
|
0.423415 ratio
Standard Deviation 0.22046721
|
0.404892 ratio
Standard Deviation 0.248163828
|
PRIMARY outcome
Timeframe: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm)Population: Each participant had urine collected at each time listed: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm). Data was collected on the Citrate/Creatinine Ratio at each time period void. Thus, at each time of day, there was an N equivalent to the number of voids across all entire 20 participant cohort. Since it was the same participant providing the void at the different times, the sum of participants does not add to the n in the study population (20).
Ca/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation
Outcome measures
| Measure |
5pm Void Post
n=19 Participants
increased fluid intake cohort 5p.m void
|
5p.m. Pre
n=20 Participants
normal fluid intake 5 p.m void
|
1-2 pm Post
n=19 Participants
void time post intervention
|
1-2pm Void Pre
n=20 Participants
void time pre intervention
|
9-10AM Post
n=20 Participants
void time post intervention
|
9-10AM Pre
n=20 Participants
void time pre intervention
|
First Void Pre
n=20 Participants
pre intervention, first void
|
First Void Post
n=20 Participants
post intervention post void
|
|---|---|---|---|---|---|---|---|---|
|
Calcium / Creatinine
|
0.162234 Ratio
Standard Deviation 0.114914139
|
0.161287 Ratio
Standard Deviation 0.166305391
|
0.137398 Ratio
Standard Deviation 0.1035436
|
0.140431 Ratio
Standard Deviation 0.153463692
|
0.126269 Ratio
Standard Deviation 0.097422413
|
0.111446 Ratio
Standard Deviation 0.072068182
|
0.160932 Ratio
Standard Deviation 0.111594912
|
0.142987 Ratio
Standard Deviation 0.108493894
|
PRIMARY outcome
Timeframe: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm)Population: Each participant had urine collected at each time listed: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm). Data was collected on the Citrate/Creatinine Ratio at each time period void. Thus, at each time of day, there was an N equivalent to the number of voids across all entire 20 participant cohort. Since it was the same participant providing the void at the different times, the sum of participants does not add to the n in the study population (20).
pH at 4 voids throughout the day. Pre = baseline fluid intake; Post
Outcome measures
| Measure |
5pm Void Post
n=19 Participants
increased fluid intake cohort 5p.m void
|
5p.m. Pre
n=20 Participants
normal fluid intake 5 p.m void
|
1-2 pm Post
n=19 Participants
void time post intervention
|
1-2pm Void Pre
n=20 Participants
void time pre intervention
|
9-10AM Post
n=20 Participants
void time post intervention
|
9-10AM Pre
n=20 Participants
void time pre intervention
|
First Void Pre
n=20 Participants
pre intervention, first void
|
First Void Post
n=20 Participants
post intervention post void
|
|---|---|---|---|---|---|---|---|---|
|
pH
|
6.52770 pH
Standard Deviation 0.479508661
|
6.32645 pH
Standard Deviation 0.666506167
|
6.34060 pH
Standard Deviation 0.621006253
|
6.37845 pH
Standard Deviation 0.616991723
|
6.43430 pH
Standard Deviation 0.729245327
|
6.24125 pH
Standard Deviation 0.70866872
|
6.08345 pH
Standard Deviation 0.47842631
|
6.01865 pH
Standard Deviation 0.477511011
|
PRIMARY outcome
Timeframe: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm)Population: Each participant had urine collected at each time listed: Day 1 (first void, 9-10 am, 1-2 pm and 5 pm) and Day 4 (first void, 9-10 am, 1-2 pm and 5 pm). Data was collected on the Citrate/Creatinine Ratio at each time period void. Thus, at each time of day, there was an N equivalent to the number of voids across all entire 20 participant cohort. Since it was the same participant providing the void at the different times, the sum of participants does not add to the n in the study population (20).
SG at 4 voids throughout the day. Pre = baseline fluid intake; Post
Outcome measures
| Measure |
5pm Void Post
n=19 Participants
increased fluid intake cohort 5p.m void
|
5p.m. Pre
n=20 Participants
normal fluid intake 5 p.m void
|
1-2 pm Post
n=20 Participants
void time post intervention
|
1-2pm Void Pre
n=20 Participants
void time pre intervention
|
9-10AM Post
n=20 Participants
void time post intervention
|
9-10AM Pre
n=20 Participants
void time pre intervention
|
First Void Pre
n=20 Participants
pre intervention, first void
|
First Void Post
n=20 Participants
post intervention post void
|
|---|---|---|---|---|---|---|---|---|
|
Specific Gravity (SG)
|
1.01725 g/mL
Standard Deviation 0.003851644
|
1.01525 g/mL
Standard Deviation 0.005773503
|
1.01725 g/mL
Standard Deviation 0.005799975
|
1.01850 g/mL
Standard Deviation 0.005745131
|
1.01950 g/mL
Standard Deviation 0.003906066
|
1.02051 g/mL
Standard Deviation 0.005058298
|
1.02000 g/mL
Standard Deviation 0.004552929
|
1.01825 g/mL
Standard Deviation 0.004537426
|
PRIMARY outcome
Timeframe: Over 4 day study periodPopulation: Each participant completed the study, having their total fluid intake measured on each day. Thus, the overall number of participants does not add to the study total (n=20) as each participant
Outcome measures
| Measure |
5pm Void Post
n=20 Participants
increased fluid intake cohort 5p.m void
|
5p.m. Pre
n=20 Participants
normal fluid intake 5 p.m void
|
1-2 pm Post
n=20 Participants
void time post intervention
|
1-2pm Void Pre
n=20 Participants
void time pre intervention
|
9-10AM Post
void time post intervention
|
9-10AM Pre
void time pre intervention
|
First Void Pre
pre intervention, first void
|
First Void Post
post intervention post void
|
|---|---|---|---|---|---|---|---|---|
|
Total Fluid Intake
|
2416.854 mL
Standard Deviation 1033
|
2625.093 mL
Standard Deviation 663.8
|
3116.562 mL
Standard Deviation 1308
|
3396.781 mL
Standard Deviation 1312
|
—
|
—
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—
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—
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Adverse Events
Normal Drinking Habits
Increased Fluid Intake and Citrate Supplementation
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