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Effect of Cola on Urinary Stone Risk Factors

Primary Purpose

Kidney Stone

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cola beverage
Deionized water
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Kidney Stone focused on measuring urolithiasis, cola

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: urolithiasis, healthy volunteer Exclusion Criteria: -

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cola beverage

Deionized water

Arm Description

Subjects will be given 500cc of Cola twice daily.

Subjects will be given 500cc of deionized water.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 7, 2006
Last Updated
May 5, 2016
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT00289120
Brief Title
Effect of Cola on Urinary Stone Risk Factors
Official Title
Effect of Cola on Urinary Stone Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
urolithiasis, cola

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cola beverage
Arm Type
Experimental
Arm Description
Subjects will be given 500cc of Cola twice daily.
Arm Title
Deionized water
Arm Type
Placebo Comparator
Arm Description
Subjects will be given 500cc of deionized water.
Intervention Type
Drug
Intervention Name(s)
Cola beverage
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Deionized water
Intervention Description
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
Primary Outcome Measure Information:
Title
The Plasma and Urine Parameters
Description
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.
Time Frame
at the end of each 6-day intervention in Cola and Water Phase
Title
The Plasma and Urine Parameters
Description
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.
Time Frame
at the end of 6-day intervention of Cola and water phase
Title
The Plasma Osmolarity
Description
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.
Time Frame
at the end of 6-day intervention of cola and water phase
Title
The Plasma and Urine Parameters
Description
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.
Time Frame
at the end of 6-day intervention of Cola and water phase
Secondary Outcome Measure Information:
Title
Total Urine Volume
Description
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.
Time Frame
at the end of each 6-day intervention in Cola and Water Phase
Title
Urinary pH
Description
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.
Time Frame
at the end of each 6-day intervention in Cola and Water Phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: urolithiasis, healthy volunteer Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Ogan, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23017784
Citation
Herrel L, Pattaras J, Solomon T, Ogan K. Urinary stone risk and cola consumption. Urology. 2012 Nov;80(5):990-4. doi: 10.1016/j.urology.2012.07.003. Epub 2012 Sep 25.
Results Reference
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Effect of Cola on Urinary Stone Risk Factors

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