NCT00381277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

Same day

First QC Date

September 26, 2006

Last Update Submit

February 18, 2011

Conditions

Urolithiasis

Keywords

nephrolithiasiscitrateoxalate

Outcome Measures

Primary Outcomes (4)

  • Urinary supersaturation of calcium oxalate

  • Urinary citrate excretion

  • Urinary calcium excretion

  • Urinary sodium excretion

Interventions

GatoradeDRUG
PerformanceDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-80 years old
  • men and women
  • able to sign informed consent

You may not qualify if:

  • history of kidney stones
  • bone disease
  • parathyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Harbor VAMC

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

UrolithiasisNephrolithiasis

Interventions

gatorade

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesKidney Diseases

Study Officials

  • David S Goldfarb, MD

    New York Harbor VAMC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
FED

Study Record Dates

First Submitted

September 26, 2006

First Posted

September 27, 2006

Study Start

March 1, 2006

Primary Completion

March 1, 2006

Study Completion

September 1, 2006

Last Updated

February 21, 2011

Record last verified: 2011-02

Locations

US(1)