Effect of Cola on Urinary Stone Risk Factors

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Kenneth Ogan, MD, Emory University

ClinicalTrials.gov Identifier:

NCT00289120

First received: February 7, 2006

Last updated: March 29, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2006

Last Updated Date

March 29, 2012

Start Date ^ICMJE

November 2003

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

kidney stone

Change History

Complete list of historical versions of study NCT00289120 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Cola on Urinary Stone Risk Factors

Official Title ^ICMJE

Effect of Cola on Urinary Stone Risk Factors

Brief Summary

Examine the effects of cola on risks of kidney stones

Detailed Description

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

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Condition ^ICMJE

Kidney Stone

Intervention ^ICMJE

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.
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

Study Arm (s)

Experimental: Cola beverage
Subjects will be given 500cc of Cola twice daily.

Intervention: Drug: Cola beverage
Placebo Comparator: Deionized water
Subjects will be given 500cc of deionized water.

Intervention: Drug: Deionized water

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

October 2011

Primary Completion Date

October 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

urolithiasis, healthy volunteer

Exclusion Criteria:

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00289120

Other Study ID Numbers ^ICMJE

133-2003, GCRC#2403

Has Data Monitoring Committee

Not Provided

Responsible Party

Kenneth Ogan, MD, Emory University

Study Sponsor ^ICMJE

Emory University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kenneth Ogan, MD

Emory University

Information Provided By

Emory University

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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