Kidney StonesNCT01330940
Effect of Diet Orange Soda on Urinary Lithogenicity
A study testing Orange soda in people with Kidney Stones and Nephrolithiasis, run by VA New York Harbor Healthcare System at 1 site in United States.
Trial summary
Beverages containing citrate may be useful in increasing urine citrate content and urine pH. Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more citrate than other similar beverages. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Stones, Nephrolithiasis, Urolithiasis
- What is being tested?
- Orange soda
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Jul 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- able to sign consent
- ability to reliably urinate into a vessel and measure urine volume
Who cannot join
- prior history of nephrolithiasis
- a known history of metabolic bone disease
- hyperthyroidism
- hyperparathyroidism or chronic kidney disease
- current use of diuretics
- current use of potassium citrate or other oral alkali supplementation and
- use of calcium supplementation that could not be stopped
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Harbor VA Medical Center
New York, New York, 10010
About this study
Beverages containing citrate may be useful in increasing urine citrate content and urine pH. Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more citrate than other similar beverages. The investigators are interested in whether diet soda will improve urine chemistry in the appropriate manner.
Read the detailed description
The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.
- Conditions
- Kidney Stones, Nephrolithiasis, Urolithiasis
- Being tested
- Orange soda
- Keywords
- Kidney stones, Calcium, citrate
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange sodaDietary supplement
32 ounces per day
| Study group | Role | What they receive |
|---|---|---|
| Water drinking | Placebo comparator | 32 ounces of water/24 hours Receives: Dietary Supplement: Orange soda |
| orange soda drinking | Active comparator | 32 ounces orange soda Receives: Dietary Supplement: Orange soda |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine citrate content
Citrate is measured in 24h urine sample and expressed as mg/day
Measured: 1 week
Secondary outcomes (1)
Change in urine pH
urine pH is measured in a 24h urine sample and has no units
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA New York Harbor Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, David S. Goldfarb, M.D., VA New York Harbor Healthcare System
- Investigators
- David S Goldfarb, MD, Principal investigator, New York Harbor VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330940
- Sponsor's protocol ID
- 1100
- Status last verified
- Sep 2012
- First submitted
- 4 Apr 2011
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diet Orange Soda on Urinary Lithogenicity
- ClinicalTrials.gov ID
- NCT01330940
- Acronym / sponsor ID
- 1100
- Conditions
- Kidney Stones, Nephrolithiasis, Urolithiasis
- Keywords
- Kidney stones, Calcium, citrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- VA New York Harbor Healthcare SystemUS federal agency
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 7 Apr 2011 (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.
Beverages containing citrate may be useful in increasing urine citrate content and urine pH. Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more citrate than other similar beverages. The investigators are interested in whether diet soda will improve urine chemistry in the appropriate manner.
Detailed description
The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water drinking | Placebo comparator | Dietary Supplement: Orange soda32 ounces of water/24 hours |
| orange soda drinking | Active comparator | Dietary Supplement: Orange soda32 ounces orange soda |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old
- able to sign consent
- ability to reliably urinate into a vessel and measure urine volume
Key exclusion criteria (7 listed)
- prior history of nephrolithiasis
- a known history of metabolic bone disease
- hyperthyroidism
- hyperparathyroidism or chronic kidney disease
- current use of diuretics
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 |
|---|---|---|
| Orange soda32 ounces per day | Dietary supplement | Water drinking, orange soda drinking |
Primary outcome
Change in urine citrate content
Time frame: 1 week
Citrate is measured in 24h urine sample and expressed as mg/day
1 secondary outcome
Change in urine pH
Time frame: One week
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 10 Sep 2012.
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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 principal investigator
New York Harbor VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange soda in people with Kidney Stones and Nephrolithiasis, 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 7 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 10 Sep 2012. 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. Some participants in this study may receive a placebo. 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?
Change in urine citrate content (time frame: 1 week). 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 10 Sep 2012.