We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Cola on Urinary Stone Risk Factors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289120
First Posted: February 9, 2006
Last Update Posted: June 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kenneth Ogan, MD, Emory University
Results First Submitted: August 14, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Kidney Stone
Interventions: Drug: Cola beverage
Drug: Deionized water

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited patients of Emory University Department of Urology

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Normal subjects and calcium oxalate stone-formers were included.

Reporting Groups
  Description
Cola First, Then Water

Phase 1: 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 wash-out period before patients entere phase 2 of thre study.

Phase 2: Subjects will be given 500cc of deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.


Participant Flow:   Overall Study
    Cola First, Then Water
STARTED   13 
COMPLETED   13 
NOT COMPLETED   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Thirteen subjects, including 10 normal subjects and 3 calcium oxalate stone-formers were enrolled in this prospective cross-over study.

Reporting Groups
  Description
Cola First, Then Water

Phase 1: 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 3-week wash out period before subjects enter phase 2 of the study.

Phase 2: Subjects will be given 500 cc of deionized water beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.


Baseline Measures
   Cola First, Then Water 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   13 
>=65 years   0 
Gender 
[Units: Participants]
 
Female   4 
Male   9 
Study participants 
[Units: Participants]
 
Normal subjects   10 
Calcium oxalate stone- formers   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Plasma and Urine Parameters   [ Time Frame: at the end of each 6-day intervention in Cola and Water Phase ]

2.  Primary:   The Plasma and Urine Parameters   [ Time Frame: at the end of 6-day intervention of Cola and water phase ]

3.  Primary:   The Plasma Osmolarity   [ Time Frame: at the end of 6-day intervention of cola and water phase ]

4.  Primary:   The Plasma and Urine Parameters   [ Time Frame: at the end of 6-day intervention of Cola and water phase ]

5.  Secondary:   Total Urine Volume   [ Time Frame: at the end of each 6-day intervention in Cola and Water Phase ]

6.  Secondary:   Urinary pH   [ Time Frame: at the end of each 6-day intervention in Cola and Water Phase ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kenneth Ogan
Organization: Emory University
phone: 404-778-4898
e-mail: kogan@emory.edu


Publications of Results:

Responsible Party: Kenneth Ogan, MD, Emory University
ClinicalTrials.gov Identifier: NCT00289120     History of Changes
Other Study ID Numbers: 0133-2003
GCRC#2403
First Submitted: February 7, 2006
First Posted: February 9, 2006
Results First Submitted: August 14, 2013
Results First Posted: July 8, 2014
Last Update Posted: June 8, 2016