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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01330940
Other study ID # 1100
Secondary ID
Status Completed
Phase N/A
First received April 4, 2011
Last updated September 6, 2012
Start date November 2009
Est. completion date July 2010

Study information

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

Clinical 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. The investigators are interested in whether diet soda will improve urine chemistry in the appropriate manner.


Description:

The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Orange soda
32 ounces per day

Locations

Country Name City State
United States New York Harbor VA Medical Center New York City New York

Sponsors (1)

Lead Sponsor Collaborator
VA New York Harbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

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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