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The Effects of Sports Drinks on Urinary Lithogenicity

Primary Purpose

Urolithiasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gatorade
Performance
Sponsored by
VA New York Harbor Healthcare System
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urolithiasis focused on measuring nephrolithiasis, citrate, oxalate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • New York Harbor VAMC

Outcomes

Primary Outcome Measures

Urinary supersaturation of calcium oxalate
Urinary citrate excretion
Urinary calcium excretion
Urinary sodium excretion

Secondary Outcome Measures

Full Information

First Posted
September 26, 2006
Last Updated
February 18, 2011
Sponsor
VA New York Harbor Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT00381277
Brief Title
The Effects of Sports Drinks on Urinary Lithogenicity
Official Title
The Effects of Sports Drinks on Urinary Lithogenicity
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
VA New York Harbor Healthcare System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
nephrolithiasis, citrate, oxalate

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gatorade
Intervention Type
Drug
Intervention Name(s)
Performance
Primary Outcome Measure Information:
Title
Urinary supersaturation of calcium oxalate
Title
Urinary citrate excretion
Title
Urinary calcium excretion
Title
Urinary sodium excretion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Goldfarb, MD
Organizational Affiliation
New York Harbor VAMC
Official's Role
Study Director
Facility Information:
Facility Name
New York Harbor VAMC
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effects of Sports Drinks on Urinary Lithogenicity

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