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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

Tracking Information
First Submitted Date  ICMJE May 30, 2018
First Posted Date  ICMJE August 24, 2018
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE August 28, 2018
Actual Primary Completion Date May 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • Citrate concentration in mg/L [ Time Frame: Day 1 ]
    Citrate concentration in mg/L as it varies through the course of the day
  • Calcium concentration in mg/dL [ Time Frame: Day 1 ]
    Calcium concentration in mg/dL as it varies through the course of the day
  • Creatinine concentration in mg/dL [ Time Frame: Day 1 ]
    Creatinine concentration in mg/dL as it varies through the course of the day
  • pH [ Time Frame: Day 1 ]
    pH variation throughout the day through the course of the day
  • Specific Gravity [ Time Frame: Day 1 ]
    Specific Gravity variation throughout the day through the course of the day
  • 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.
  • 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.
  • 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.
  • pH [ Time Frame: Day 4 ]
    pH variation throughout the day through the course of the day with increase in fluid intake.
  • Specific Gravity [ Time Frame: Day 4 ]
    Specific Gravity variation throughout the day through the course of the day with increase in fluid intake.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03645785 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2018)
  • 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
  • prolonged time of void to assessment [ Time Frame: Day 4 ]
    Assess if prolonged time of void to assessment effects pH and specific gravity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day
Official Title  ICMJE Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day and the Effect of Increased Fluid Intake on Intra-Day Urine Composition
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Normal fluid intake without true lemon
    16.9oz water with True Lemon
  • Dietary Supplement: Double fluid intake plus 3 bottles of water with True Lemon
    No intervention
Study Arms  ICMJE
  • Active Comparator: Normal drinking habits
    Normal fluid intake without True lemon
    Intervention: Dietary Supplement: Normal fluid intake without true lemon
  • Experimental: Increased fluid Intake
    Double fluid intake plus 3 bottles of water with True Lemon
    Intervention: Dietary Supplement: Double fluid intake plus 3 bottles of water with True Lemon
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2019)
23
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2018)
20
Actual Study Completion Date  ICMJE May 20, 2019
Actual Primary Completion Date May 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adult subjects

Exclusion Criteria:

  • Subjects taking diuretics
  • Subjects who have known kidney disease
  • Subjects with history of known nephrolithiasis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03645785
Other Study ID Numbers  ICMJE AMC5086
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adam Howe, MD, Albany Medical College
Study Sponsor  ICMJE Adam Howe, MD
Collaborators  ICMJE Litholink
Investigators  ICMJE
Principal Investigator: Adam Howe, MD Albany Medical College
PRS Account Albany Medical College
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP