Urolithiasis Clinical Trial
Official title:
Effect of Diet Orange Soda on Urinary Lithogenicity
Verified date | September 2012 |
Source | VA New York Harbor Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 18-65 years old - able to sign consent - ability to reliably urinate into a vessel and measure urine volume Exclusion Criteria: - 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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | New York Harbor VA Medical Center | New York City | New York |
Lead Sponsor | Collaborator |
---|---|
VA New York Harbor Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in urine citrate content | Citrate is measured in 24h urine sample and expressed as mg/day | 1 week | No |
Secondary | Change in urine pH | urine pH is measured in a 24h urine sample and has no units | One week | No |
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