Effect of Cola on Urinary Stone Risk Factors

Not Applicable

Completed

• Conditions: Kidney Stone
• Interventions: Drug: Deionized water; Drug: Cola beverage

• Registration Number: NCT00289120
• Lead Sponsor: Emory University

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 Timeline

• Study Start: 2003-11
• Study First Submitted: 2006-02-07
• Study First Submitted QC: 2006-02-07
• Study First Posted: 2006-02-09
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2013-08-14
• Results First Submitted QC: 2014-06-05
• Results First Posted: 2014-07-08
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-05
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• urolithiasis, healthy volunteer

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Deionized water	Deionized water	Subjects will be given 500cc of deionized water.
Cola beverage	Cola beverage	Subjects will be given 500cc of Cola twice daily.

Primary Outcome Measures

Name	Time	Method
The Plasma and Urine Parameters	at the end of 6-day intervention of Cola and water phase	The Urine Parameters that were assessed at the end of cola and water (arms) phase: Urine Parameters: uNa (mEq per d) uK (mEq per d); The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).; measure of dispersion was standard deviation.
The Plasma Osmolarity	at the end of 6-day intervention of cola and water phase	The Plasma osmolarity that were assessed at the end of cola and water (arms) phase: Plasma Parameters: OSM (mOsm/L); The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).; measure of dispersion was standard deviation.

Secondary Outcome Measures

Name	Time	Method
Urinary pH	at the end of each 6-day intervention in Cola and Water Phase	The Urine pH that were assessed at the end of cola and water (arms) phase The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).; measure of dispersion was standard deviation.
Total Urine Volume	at the end of each 6-day intervention in Cola and Water Phase	The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase: Urine Parameters: Total Urine Volume (mL/day); The parameters were consolidated into the one value as a mean of all the values in the phase or group (Table 3) and later for longitudinal analysis as a mean of all the values in the phase for each participant (Table 4).; measure of dispersion was standard deviation.

Trial Locations

Locations (1)

Emory University; 🇺🇸 Atlanta, Georgia, United States