HealthyNCT03645785

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

A study testing Normal fluid intake without true lemon and Double fluid intake plus 3 bottles of water with True Lemon in people with Healthy, run by Adam Howe, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Normal fluid intake without true lemon and Double fluid intake plus 3 bottles of water with True Lemon
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: 28 Aug 2018to 20 May 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adult subjects

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Albany Medical College
Albany, New York, 12208

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Healthy
Being tested: Normal fluid intake without true lemon, Double fluid intake plus 3 bottles of water with True Lemon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Normal fluid intake without true lemonDietary supplement
16.9oz water with True Lemon
Double fluid intake plus 3 bottles of water with True LemonDietary supplement
No intervention

Study groups in NCT03645785
Study group	Role	What they receive
Normal Diet/Drinking	Active comparator	Baseline diet and drinking patterns for patients. This is the pre-intervention baseline for cross-over analysis Receives: 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). Receives: Dietary Supplement: Double fluid intake plus 3 bottles of water with True Lemon

What is being measured

The primary outcome is the main question the study is designed to answer.

Citrate/Creatinine Ratio
Citrate/Cr at 4 voids throughout the day. Pre = baseline fluid intake; Post = increased fluid and citrate supplementation
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Over 4 day study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 201820 May 2019

First posted24 Aug 2018
Study start28 Aug 2018
Primary completion20 May 2019
Study completion20 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (21)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Crossover
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)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03645785
Sponsor's protocol ID: AMC5086
Status last verified: Feb 2021
First submitted: 30 May 2018
Last updated: 21 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 26022722
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.
PubMed 27228999
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.
PubMed 22498635
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.
PubMed 24857648
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.
PubMed 19914693
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.
PubMed 27286119
Strohmaier WL, Hoelz KJ, Bichler KH. Spot urine samples for the metabolic evaluation of urolithiasis patients. Eur Urol. 1997;32(3):294-300.
PubMed 9358216
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.
PubMed 19555813
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.
PubMed 3454077
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.
PubMed 25283761
Simerville JA, Maxted WC, Pahira JJ. Urinalysis: a comprehensive review. Am Fam Physician. 2005 Mar 15;71(6):1153-62.
PubMed 15791892
Hardy PE. Urinalysis interpretation. Neonatal Netw. 2010 Jan-Feb;29(1):45-9. doi: 10.1891/0730-0832.29.1.45. No abstract available.
PubMed 20085877
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.
PubMed 22700881
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.
PubMed 17162145
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.
PubMed 11380833

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03645785
Acronym / sponsor ID: AMC5086
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Adam Howe, MDUniversity, hospital or other
Collaborators: Labcorp Corporation of America Holdings, Inc
Study start: 28 Aug 2018 (actual)
Primary completion: 20 May 2019 (actual)
Study completion: 20 May 2019 (actual)
First posted: 24 Aug 2018 (actual)
Results: Posted 21 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
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

Arm	Type	Receives
Normal Diet/Drinking	Active comparator	Dietary Supplement: Normal fluid intake without true lemonBaseline diet and drinking patterns for patients. This is the pre-intervention baseline for cross-over analysis
Increased fluid Intake and Citrate Supplementation	Experimental	Dietary Supplement: Double fluid intake plus 3 bottles of water with True LemonPatients will increase fluid (with goal to double their baseline) and further take a citrate supplement in the form of True Lemon (citric acid).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Healthy adult subjects

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Normal fluid intake without true lemon16.9oz water with True Lemon	Dietary supplement	Normal Diet/Drinking
Double fluid intake plus 3 bottles of water with True LemonNo intervention	Dietary supplement	Increased fluid Intake and Citrate Supplementation

Primary outcome

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

Results and safety

Results posted to the registry on 21 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-Stone Forming	23	23

Primary outcome: 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). Mean (Standard Deviation). Unit: ratio

Measure	5pm Void Post n = 19	5p.m. Pre n = 20	1-2 pm Post n = 19	1-2pm Void Pre n = 20	9-10AM Post n = 20	9-10AM Pre n = 20	First Void Pre n = 20	First Void Post n = 20
Value	0.658644 (0.429258801)	0.584115 (0.393029128)	0.562886 (0.309518524)	0.540394 (0.332082046)	0.490685 (0.246362039)	0.441938 (0.209042617)	0.423415 (0.22046721)	0.404892 (0.248163828)

Population analysed: Each participant had urine collected at each time listed: 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). Data was collected on the Citrate/Creatinine Ratio at each time period void. Thus, at each time of day, there was an N equivalent to the number of voids across all entire 20 participant cohort. Since it was the same participant providing the void at the different times, the sum of participants does not add to the n in the study population (20).

Primary outcome: 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). Mean (Standard Deviation). Unit: Ratio

Measure	5pm Void Post n = 19	5p.m. Pre n = 20	1-2 pm Post n = 19	1-2pm Void Pre n = 20	9-10AM Post n = 20	9-10AM Pre n = 20	First Void Pre n = 20	First Void Post n = 20
Value	0.162234 (0.114914139)	0.161287 (0.166305391)	0.137398 (0.1035436)	0.140431 (0.153463692)	0.126269 (0.097422413)	0.111446 (0.072068182)	0.160932 (0.111594912)	0.142987 (0.108493894)

Primary outcome: 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). Mean (Standard Deviation). Unit: pH

Measure	5pm Void Post n = 19	5p.m. Pre n = 20	1-2 pm Post n = 19	1-2pm Void Pre n = 20	9-10AM Post n = 20	9-10AM Pre n = 20	First Void Pre n = 20	First Void Post n = 20
Value	6.52770 (0.479508661)	6.32645 (0.666506167)	6.34060 (0.621006253)	6.37845 (0.616991723)	6.43430 (0.729245327)	6.24125 (0.70866872)	6.08345 (0.47842631)	6.01865 (0.477511011)

Primary outcome: 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). Mean (Standard Deviation). Unit: g/mL

Measure	5pm Void Post n = 19	5p.m. Pre n = 20	1-2 pm Post n = 20	1-2pm Void Pre n = 20	9-10AM Post n = 20	9-10AM Pre n = 20	First Void Pre n = 20	First Void Post n = 20
Value	1.01725 (0.003851644)	1.01525 (0.005773503)	1.01725 (0.005799975)	1.01850 (0.005745131)	1.01950 (0.003906066)	1.02051 (0.005058298)	1.02000 (0.004552929)	1.01825 (0.004537426)

Adverse events

Time frame: 4 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Drinking Habits	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Increased Fluid Intake and Citrate Supplementation	0 of 23 (0%)	0 of 23 (0%)	0 of 23

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26022722Cheungpasitporn 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.
Background: PubMed 27228999Lotan 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.
Background: PubMed 22498635Scales 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.
Background: PubMed 24857648Pearle 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.
Background: PubMed 19914693Hong 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.
Background: PubMed 27286119Omar 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.
Background: PubMed 9358216Strohmaier WL, Hoelz KJ, Bichler KH. Spot urine samples for the metabolic evaluation of urolithiasis patients. Eur Urol. 1997;32(3):294-300.
Background: PubMed 19555813Fenton 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.
Background: PubMed 3454077Matsushita 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.
Background: PubMed 25283761Utsch 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.
Background: PubMed 15791892Simerville JA, Maxted WC, Pahira JJ. Urinalysis: a comprehensive review. Am Fam Physician. 2005 Mar 15;71(6):1153-62.
Background: PubMed 20085877Hardy PE. Urinalysis interpretation. Neonatal Netw. 2010 Jan-Feb;29(1):45-9. doi: 10.1891/0730-0832.29.1.45. No abstract available.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Adam Howe, MD principal investigator

Albany Medical College

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Normal fluid intake without true lemon and Double fluid intake plus 3 bottles of water with True Lemon in people with Healthy, run by Adam Howe, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03645785, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.