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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00381277
Other study ID # DG-1
Secondary ID
Status Completed
Phase N/A
First received September 26, 2006
Last updated February 18, 2011
Start date March 2006
Est. completion date September 2006

Study information

Verified date February 2011
Source VA New York Harbor Healthcare System
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUnited States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date September 2006
Est. primary completion date March 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- age 18-80 years old

- men and women

- able to sign informed consent

Exclusion Criteria:

- history of kidney stones

- bone disease

- parathyroid disease

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Gatorade

Performance


Locations

Country Name City State
United States New York Harbor VAMC New York 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 Urinary supersaturation of calcium oxalate
Primary Urinary citrate excretion
Primary Urinary calcium excretion
Primary Urinary sodium excretion
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