Effect of Cola on Urinary Stone Risk Factors

Kidney Stone Clinical Trial

Official title:

Effect of Cola on Urinary Stone Risk Factors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289120
• Other study ID #: 0133-2003
• Secondary ID: GCRC#2403
• Status: Completed
• Phase: N/A
• First received: February 7, 2006
• Last updated: June 5, 2014
• Start date: November 2003
• Est. completion date: October 2011

Study information

• Verified date: June 2014
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Examine the effects of cola on risks of kidney stones

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• urolithiasis, healthy volunteer

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Urinary Calculi

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Plasma and Urine Parameters	The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase: Plasma Parameters: CA (mg per dL) GLU (mg per dL) BUN (mg per dL) Cr (mg per dL) Prot (mg per dL) ALB (mg per dL); Urine Parameters: uCa (mg per dL) uMg (mg per dL) uP (mg per dL) uCr (mg per dL) uCit (mg per dL) uOx (mg per dL) uUA (mg per dL); 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.	at the end of each 6-day intervention in Cola and Water Phase	No
Primary	The Plasma and Urine Parameters	The Plasma and Urine Parameters that were assessed at the end of cola and water (arms) phase: Plasma Parameters: Na (mEq per L) K (mEq per L) CL (mEq per L) CO2(mEq per L) AG (mEq per 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.	at the end of 6-day intervention of Cola and water phase	No
Primary	The Plasma Osmolarity	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.	at the end of 6-day intervention of cola and water phase	No
Primary	The Plasma and Urine Parameters	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.	at the end of 6-day intervention of Cola and water phase	No
Secondary	Total Urine Volume	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.	at the end of each 6-day intervention in Cola and Water Phase	No
Secondary	Urinary pH	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.	at the end of each 6-day intervention in Cola and Water Phase	No