Effect of Cola on Urinary Stone Risk Factors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00289120
First received: February 7, 2006
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

Examine the effects of cola on risks of kidney stones


Condition Intervention
Kidney Stone
Drug: Cola beverage
Drug: Deionized water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Effect of Cola on Urinary Stone Risk Factors

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Effect of cola [ Time Frame: 6 days with 3 weeks interval before crossover ] [ Designated as safety issue: Yes ]
    Effect of cola on the urine levels of: Ca, Oxalate, Uric Acid, Citrate, pH, total volume, Na, P, Mg, K and Cr.


Enrollment: 24
Study Start Date: November 2003
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cola beverage
Subjects will be given 500cc of Cola twice daily.
Drug: Cola beverage
Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.There will be a three weeks interval before crossover to the other treatment arm.
Placebo Comparator: Deionized water
Subjects will be given 500cc of deionized water.
Drug: Deionized water
Subjects will be given 500cc of deionized water to be ingested twice daily with breakfast and dinner for three weeks while on a metabolic diet. There will be a three weeks interval before crossover to the other treatment arm

Detailed Description:

Prospective crossover study examining the risks of cola on stone risk factors.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • urolithiasis, healthy volunteer

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289120

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Kenneth Ogan, MD Emory University
  More Information

No publications provided

Responsible Party: Kenneth Ogan, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00289120     History of Changes
Other Study ID Numbers: 133-2003, GCRC#2403
Study First Received: February 7, 2006
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
urolithiasis, cola

Additional relevant MeSH terms:
Calculi
Kidney Calculi
Nephrolithiasis
Urinary Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis

ClinicalTrials.gov processed this record on April 15, 2014