UrolithiasisNCT00381277
The Effects of Sports Drinks on Urinary Lithogenicity
A study testing Gatorade and Performance in people with Urolithiasis, run by VA New York Harbor Healthcare System at 1 site in United States.
Trial summary
The effect of sports drinks on the tendency to form kidney stones has not been assessed. Patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes in urine chemistry that may decrease the risk of forming stones. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Gatorade and Performance
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-80 years old
- men and women
- able to sign informed consent
Who cannot join
- history of kidney stones
- bone disease
- parathyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
The effect of sports drinks on the tendency to form kidney stones has not been assessed. Patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes in urine chemistry that may decrease the risk of forming stones.
Read the detailed description
Participants will drink 1 liter of water each day for one week in the control period, then 1 liter of sports drink each day for one week during the experimental period. Urine collections will be performed during both periods. Diet will be chosen by participants and a food diary will be kept so that participants can replicate diet during the urine collections.
- Conditions
- Urolithiasis
- Being tested
- Gatorade, Performance
- Keywords
- nephrolithiasis, citrate, oxalate
- Medical subject headings
- Urolithiasis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GatoradeDrug
PerformanceDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary supersaturation of calcium oxalate
Urinary citrate excretion
Urinary calcium excretion
Urinary sodium excretion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Investigators
- David S Goldfarb, MD, Study director, New York Harbor VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381277
- Sponsor's protocol ID
- DG-1
- Status last verified
- Feb 2011
- First submitted
- 26 Sep 2006
- Last updated
- 21 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sports Drinks on Urinary Lithogenicity
- ClinicalTrials.gov ID
- NCT00381277
- Acronym / sponsor ID
- DG-1
- Conditions
- Urolithiasis
- Keywords
- nephrolithiasis, citrate, oxalate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Study start
- Mar 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of sports drinks on the tendency to form kidney stones has not been assessed. Patients will drink 1 liter a day of 2 sports drinks and collect urine to determine changes in urine chemistry that may decrease the risk of forming stones.
Detailed description
Participants will drink 1 liter of water each day for one week in the control period, then 1 liter of sports drink each day for one week during the experimental period. Urine collections will be performed during both periods. Diet will be chosen by participants and a food diary will be kept so that participants can replicate diet during the urine collections.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-80 years old
- men and women
- able to sign informed consent
Key exclusion criteria (3 listed)
- history of kidney stones
- bone disease
- parathyroid disease
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 |
|---|---|---|
| Gatorade | Drug | – |
| Performance | Drug | – |
Primary outcome
Urinary supersaturation of calcium oxalate
Urinary citrate excretion
Urinary calcium excretion
Urinary sodium excretion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2011.
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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.
David S Goldfarb, MD study director
New York Harbor VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gatorade and Performance in people with Urolithiasis, run by VA New York Harbor Healthcare System 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 3 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 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Urinary supersaturation of calcium oxalate. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2011; AzTrials last refreshed its copy on 7 Nov 2026.