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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
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
Litholink
Information provided by (Responsible Party):
Adam Howe, MD, Albany Medical College

Brief Summary:
This study is a prospective study looking at healthy adults who will have urine collected at 4 set times throughout the course of the day. On Day 2, 3, and 4 subjects will drink a bottle of water containing True lemon and on days 2 and 3 double the amount of fluid intake from Day 1. On day 4 the subject will collect urine samples at 4 set times throughout the day. The pH of all of the urine samples will be checked with a urine dipstick and the samples will be sent to Litholink Lab for electrolyte composition analysis.

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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Normal drinking habits
Normal fluid intake without True lemon
Dietary Supplement: Normal fluid intake without true lemon
16.9oz water with True Lemon

Experimental: Increased fluid Intake
Double fluid intake plus 3 bottles of water with True Lemon
Dietary Supplement: Double fluid intake plus 3 bottles of water with True Lemon
No intervention




Primary Outcome Measures :
  1. Citrate concentration in mg/L [ Time Frame: Day 1 ]
    Citrate concentration in mg/L as it varies through the course of the day

  2. Calcium concentration in mg/dL [ Time Frame: Day 1 ]
    Calcium concentration in mg/dL as it varies through the course of the day

  3. Creatinine concentration in mg/dL [ Time Frame: Day 1 ]
    Creatinine concentration in mg/dL as it varies through the course of the day

  4. pH [ Time Frame: Day 1 ]
    pH variation throughout the day through the course of the day

  5. Specific Gravity [ Time Frame: Day 1 ]
    Specific Gravity variation throughout the day through the course of the day

  6. Citrate concentration in mg/L [ Time Frame: Day 4 ]
    Citrate concentration in mg/L as it varies through the course of the day with increase in fluid intake.

  7. Calcium concentration in mg/dL [ Time Frame: Day 4 ]
    Calcium concentration in mg/dL as it varies through the course of the day with increase in fluid intake.

  8. Creatinine concentration in mg/dL [ Time Frame: Day 4 ]
    Creatinine concentration in mg/dL as it varies through the course of the day, with increase in fluid intake.

  9. pH [ Time Frame: Day 4 ]
    pH variation throughout the day through the course of the day with increase in fluid intake.

  10. Specific Gravity [ Time Frame: Day 4 ]
    Specific Gravity variation throughout the day through the course of the day with increase in fluid intake.


Secondary Outcome Measures :
  1. Association between urine electrolyte, pH and specific gravity variation [ Time Frame: Day 4 ]
    Assess whether there is any association between urine electrolyte, pH and specific gravity variation with respect to demographic features such as diet, age, BMI

  2. prolonged time of void to assessment [ Time Frame: Day 4 ]
    Assess if prolonged time of void to assessment effects pH and specific gravity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult subjects

Exclusion Criteria:

  • Subjects taking diuretics
  • Subjects who have known kidney disease
  • Subjects with history of known nephrolithiasis

Information from the National Library of Medicine

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


Locations
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United States, New York
Albany Medical College
Albany, New York, United States, 12208
Sponsors and Collaborators
Adam Howe, MD
Litholink
Investigators
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Principal Investigator: Adam Howe, MD Albany Medical College

Publications:

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Responsible Party: Adam Howe, MD, Assistant Professor of Surgery, Albany Medical College
ClinicalTrials.gov Identifier: NCT03645785     History of Changes
Other Study ID Numbers: AMC5086
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No