Variation in Urine Electrolytes, pH and Specific Gravity Throughout the Day

NCT03645785 | Completed Results

• 1 other identifier: AMC5086
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Citrate/Creatinine Ratio

  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

  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

  pH 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)

• Specific Gravity (SG)

  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

  Over 4 day study period

Study Arms (2)

Normal Diet/Drinking

ACTIVE COMPARATOR

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

Increased fluid Intake and Citrate Supplementation

EXPERIMENTAL

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

Interventions

Normal fluid intake without true lemon DIETARY_SUPPLEMENT

16.9oz water with True Lemon

Normal Diet/Drinking

Double fluid intake plus 3 bottles of water with True Lemon DIETARY_SUPPLEMENT

No intervention

Increased fluid Intake and Citrate Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult subjects

You may not qualify if:

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

Sponsors & Collaborators

• Adam Howe, MD: lead
• Labcorp Corporation of America Holdings, Inc: collaborator

Study Sites (1)

Albany Medical College

Albany, New York, 12208, United States

Location

Related Publications (21)

• 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.

  PMID: 26022722 BACKGROUND

• 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.

  PMID: 27228999 BACKGROUND

• 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.

  PMID: 22498635 BACKGROUND

• 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.

  PMID: 24857648 BACKGROUND

• 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.

  PMID: 19914693 BACKGROUND

• 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.

  PMID: 27286119 BACKGROUND

• Strohmaier WL, Hoelz KJ, Bichler KH. Spot urine samples for the metabolic evaluation of urolithiasis patients. Eur Urol. 1997;32(3):294-300.

  PMID: 9358216 BACKGROUND

• 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.

  PMID: 19555813 BACKGROUND

• 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.

  PMID: 3454077 BACKGROUND

• 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.

  PMID: 25283761 BACKGROUND

• Simerville JA, Maxted WC, Pahira JJ. Urinalysis: a comprehensive review. Am Fam Physician. 2005 Mar 15;71(6):1153-62.

  PMID: 15791892 BACKGROUND

• Hardy PE. Urinalysis interpretation. Neonatal Netw. 2010 Jan-Feb;29(1):45-9. doi: 10.1891/0730-0832.29.1.45. No abstract available.

  PMID: 20085877 BACKGROUND

• 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.

  PMID: 22700881 BACKGROUND

• 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.

  PMID: 17162145 BACKGROUND

• 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.

  PMID: 11380833 BACKGROUND

• 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.

  PMID: 27012033 BACKGROUND

• 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.

  PMID: 26598386 BACKGROUND

• 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.

  PMID: 10979067 BACKGROUND

• 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.

  PMID: 12507982 BACKGROUND

• 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.

  PMID: 18715937 BACKGROUND

• 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.

  PMID: 18578664 BACKGROUND

Limitations and Caveats

Small number of study participants. Perhaps because we required participants to submit four fresh urine samples promptly throughout two separate days, 3 days apart, recruitment for the study was difficult. No nighttime urine collections. Further, we did not collect 24 hour urine samples simultaneously with the spot urines. One further limitation is that this looked at normal control patients only.

Results Point of Contact

• Title: Vikas Bhatt
• Organization: Albany Medical Center

bhattv@amc.edu

5182623341

Study Officials

• Adam Howe, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: 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

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: August 24, 2018
• Study Start: August 28, 2018
• Primary Completion: May 20, 2019
• Study Completion: May 20, 2019
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)