Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day
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|ClinicalTrials.gov Identifier: NCT03645785|
Recruitment Status : Completed
First Posted : August 24, 2018
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Normal fluid intake without true lemon Dietary Supplement: Double fluid intake plus 3 bottles of water with True Lemon||Not Applicable|
20 subjects will be recruited and consented in the Urology Clinic office. Subjects will complete a questionnaire asking about weight, height, history of kidney stones, whether they are on any diuretics, medications that alter urine chemistries, or special diets. BMI will be calculated. Day 1 will begin at 5p.m. on the day before first morning void is collected. The subjects will collect a spot urine sample on the first void at home, then at 9-10AM, 1-2 PM and 4-5PM. They will be provided 4 sterile urine cups labeled for the different timed collection marked at the 20-30 ml line to indicate how much urine should be collected. Subjects will be instructed to refrigerate their first voids.The 2nd, 3rd and 4th void samples will be collected in the office during the designated times, and given to study personnel. The subjects will record the time of each void, the time given to the study representative, the times they eat, and their approximate fluid intake on the provided diaries. Subjects will be asked not to void outside of the timed collections. If they do void outside of these times, they will be asked to record the extra times that they void.
On Day 2, 3, and 4 the subject will drink a bottle of water with True Lemon after 5pm. On days 3 and 4 the subjects will double their fluid intake using Day 1 as a guide. On Day 4 the subjects will collect 4 urine samples as previously described for Day1. They will be instructed to mix 1 packet of True lemon in one 16.9oz (500 mL) bottle of Poland Spring. All True Lemon packets (True Citrus, 11501 Pocomoke Court Suite D, Baltimore, MD 21220). and Poland Spring (Nestle Waters North America) bottles will be provided to subjects by the research study team.
UA dipsticks will be used in office to evaluate for pH and specific gravity. Samples will also be sent to lab for evaluation of chemical composition of creatinine, citrate, and calcium. Electrolytes will be indexed against creatinine to evaluate their concentrations without having a 24-hour void volume amount A sample of citrate-Poland Spring will be sent to Litholink for analysis of Calcium and Citrate for reference.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||All subjects will collect 4 urine samples on Day1 and Day 4. On day 2, 3 and 4 all subjects will drink a bottle of water with True Lemon and collect another 4 urine samples on day 4|
|Masking:||None (Open Label)|
|Official Title:||Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day and the Effect of Increased Fluid Intake on Intra-Day Urine Composition|
|Actual Study Start Date :||August 28, 2018|
|Actual Primary Completion Date :||May 20, 2019|
|Actual Study Completion Date :||May 20, 2019|
Active Comparator: Normal Diet/Drinking
Baseline diet and drinking patterns for patients. This is the pre-intervention baseline for cross-over analysis
Dietary Supplement: Normal fluid intake without true lemon
16.9oz water with True Lemon
Experimental: Increased fluid Intake and Citrate Supplementation
Patients will increase fluid (with goal to double their baseline) and further take a citrate supplement in the form of True Lemon (citric acid).
Dietary Supplement: Double fluid intake plus 3 bottles of water with True Lemon
- Citrate/Creatinine Ratio [ Time Frame: 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) ]Citrate/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation
- Calcium / Creatinine [ Time Frame: 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) ]Ca/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation
- pH [ Time Frame: 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) ]pH at 4 voids throughout the day. Pre = baseline fluid intake; Post
- Specific Gravity (SG) [ Time Frame: 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) ]SG at 4 voids throughout the day. Pre = baseline fluid intake; Post
- Total Fluid Intake [ Time Frame: Over 4 day study period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645785
|United States, New York|
|Albany Medical College|
|Albany, New York, United States, 12208|
|Principal Investigator:||Adam Howe, MD||Albany Medical College|