- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03645785
Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day
Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day and the Effect of Increased Fluid Intake on Intra-Day Urine Composition
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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Albany, New York, United States, 12208
- Albany Medical College
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adult subjects
Exclusion Criteria:
- Subjects taking diuretics
- Subjects who have known kidney disease
- Subjects with history of known nephrolithiasis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Normal Diet/Drinking
Baseline diet and drinking patterns for patients.
This is the pre-intervention baseline for cross-over analysis
|
16.9oz water with True Lemon
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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).
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No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
|
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
|
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
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
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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)
|
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
|
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)
|
Total Fluid Intake
Time Frame: Over 4 day study period
|
Over 4 day study period
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Cheungpasitporn W, Rossetti S, Friend K, Erickson SB, Lieske JC. Treatment effect, adherence, and safety of high fluid intake for the prevention of incident and recurrent kidney stones: a systematic review and meta-analysis. J Nephrol. 2016 Apr;29(2):211-219. doi: 10.1007/s40620-015-0210-4. Epub 2015 May 29.
- Lotan Y, Antonelli J, Jimenez IB, Gharbi H, Herring R, Beaver A, Dennis A, Von Merveldt D, Carter S, Cohen A, Poindexter J, Moe OW, Pearle MS. The kidney stone and increased water intake trial in steel workers: results from a pilot study. Urolithiasis. 2017 Apr;45(2):177-183. doi: 10.1007/s00240-016-0892-7. Epub 2016 May 26.
- Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
- Pearle MS, Goldfarb DS, Assimos DG, Curhan G, Denu-Ciocca CJ, Matlaga BR, Monga M, Penniston KL, Preminger GM, Turk TM, White JR; American Urological Assocation. Medical management of kidney stones: AUA guideline. J Urol. 2014 Aug;192(2):316-24. doi: 10.1016/j.juro.2014.05.006. Epub 2014 May 20.
- Hong YH, Dublin N, Razack AH, Mohd MA, Husain R. Twenty-four hour and spot urine metabolic evaluations: correlations versus agreements. Urology. 2010 Jun;75(6):1294-8. doi: 10.1016/j.urology.2009.08.061. Epub 2009 Nov 14.
- Omar M, Sarkissian C, Jianbo L, Calle J, Monga M. Dipstick Spot urine pH does not accurately represent 24 hour urine PH measured by an electrode. Int Braz J Urol. 2016 May-Jun;42(3):546-9. doi: 10.1590/S1677-5538.IBJU.2015.0071.
- Strohmaier WL, Hoelz KJ, Bichler KH. Spot urine samples for the metabolic evaluation of urolithiasis patients. Eur Urol. 1997;32(3):294-300.
- Fenton TR, Eliasziw M, Lyon AW, Tough SC, Brown JP, Hanley DA. Low 5-year stability of within-patient ion excretion and urine pH in fasting-morning-urine specimens. Nutr Res. 2009 May;29(5):320-6. doi: 10.1016/j.nutres.2009.04.005.
- Matsushita K, Tanikawa K. Significance of the calcium to creatinine concentration ratio of a single-voided urine specimen in patients with hypercalciuric urolithiasis. Tokai J Exp Clin Med. 1987 Sep;12(3):167-71.
- Utsch B, Klaus G. Urinalysis in children and adolescents. Dtsch Arztebl Int. 2014 Sep 12;111(37):617-25; quiz 626. doi: 10.3238/arztebl.2014.0617.
- Simerville JA, Maxted WC, Pahira JJ. Urinalysis: a comprehensive review. Am Fam Physician. 2005 Mar 15;71(6):1153-62. Erratum In: Am Fam Physician. 2006 Oct 1;74(7):1096.
- Hardy PE. Urinalysis interpretation. Neonatal Netw. 2010 Jan-Feb;29(1):45-9. doi: 10.1891/0730-0832.29.1.45. No abstract available.
- Yi JH, Shin HJ, Kim SM, Han SW, Kim HJ, Oh MS. Does the exposure of urine samples to air affect diagnostic tests for urine acidification? Clin J Am Soc Nephrol. 2012 Aug;7(8):1211-6. doi: 10.2215/CJN.03230312. Epub 2012 Jun 14.
- Taylor EN, Curhan GC. Body size and 24-hour urine composition. Am J Kidney Dis. 2006 Dec;48(6):905-15. doi: 10.1053/j.ajkd.2006.09.004.
- Curhan GC, Willett WC, Speizer FE, Stampfer MJ. Twenty-four-hour urine chemistries and the risk of kidney stones among women and men. Kidney Int. 2001 Jun;59(6):2290-8. doi: 10.1046/j.1523-1755.2001.00746.x.
- Ahmed AI, Baz H, Lotfy S. Urinalysis: The Automated Versus Manual Techniques; Is It Time To Change? Clin Lab. 2016;62(1-2):49-56. doi: 10.7754/clin.lab.2015.150520.
- LaRocco MT, Franek J, Leibach EK, Weissfeld AS, Kraft CS, Sautter RL, Baselski V, Rodahl D, Peterson EJ, Cornish NE. Effectiveness of Preanalytic Practices on Contamination and Diagnostic Accuracy of Urine Cultures: a Laboratory Medicine Best Practices Systematic Review and Meta-analysis. Clin Microbiol Rev. 2016 Jan;29(1):105-47. doi: 10.1128/CMR.00030-15.
- Lifshitz E, Kramer L. Outpatient urine culture: does collection technique matter? Arch Intern Med. 2000 Sep 11;160(16):2537-40. doi: 10.1001/archinte.160.16.2537.
- Morimoto M, Yanai H, Shukuya K, Chiba H, Kobayashi K, Matsuno K. Effects of midstream collection and the menstrual cycle on urine particles and dipstick urinalysis among healthy females. Clin Chem. 2003 Jan;49(1):188-90. doi: 10.1373/49.1.188. No abstract available.
- Worcester EM, Coe FL, Evan AP, Bergsland KJ, Parks JH, Willis LR, Clark DL, Gillen DL. Evidence for increased postprandial distal nephron calcium delivery in hypercalciuric stone-forming patients. Am J Physiol Renal Physiol. 2008 Nov;295(5):F1286-94. doi: 10.1152/ajprenal.90404.2008. Epub 2008 Aug 20.
- Desai RA, Assimos DG. Accuracy of urinary dipstick testing for pH manipulation therapy. J Endourol. 2008 Jun;22(6):1367-70. doi: 10.1089/end.2008.0053.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AMC5086
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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