Back to resultsEffect of Diet Orange Soda on Urinary Lithogenicity
Primary Purpose
Kidney Stones, Nephrolithiasis, Urolithiasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orange soda
Sponsored by
About this trial
This is an interventional prevention trial for Kidney Stones focused on measuring Kidney stones, Calcium, citrate
Eligibility Criteria
Inclusion Criteria:
- 18-65 years old
- able to sign consent
- ability to reliably urinate into a vessel and measure urine volume
Exclusion Criteria:
- prior history of nephrolithiasis
- a known history of metabolic bone disease
- hyperthyroidism
- hyperparathyroidism or chronic kidney disease
- current use of diuretics
- current use of potassium citrate or other oral alkali supplementation and
- use of calcium supplementation that could not be stopped
Sites / Locations
- New York Harbor VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Water drinking
orange soda drinking
Arm Description
32 ounces of water/24 hours
32 ounces orange soda
Outcomes
Primary Outcome Measures
Change in urine citrate content
Citrate is measured in 24h urine sample and expressed as mg/day
Secondary Outcome Measures
Change in urine pH
urine pH is measured in a 24h urine sample and has no units
Full Information
NCT ID
NCT01330940
First Posted
April 4, 2011
Last Updated
September 6, 2012
Sponsor
VA New York Harbor Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01330940
Brief Title
Effect of Diet Orange Soda on Urinary Lithogenicity
Official Title
Effect of Diet Orange Soda on Urinary Lithogenicity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA New York Harbor Healthcare System
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Beverages containing citrate may be useful in increasing urine citrate content and urine pH. Such changes in urine chemistry could help prevent kidney stones. Diet orange soda has more citrate than other similar beverages. The investigators are interested in whether diet soda will improve urine chemistry in the appropriate manner.
Detailed Description
The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stones, Nephrolithiasis, Urolithiasis
Keywords
Kidney stones, Calcium, citrate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water drinking
Arm Type
Placebo Comparator
Arm Description
32 ounces of water/24 hours
Arm Title
orange soda drinking
Arm Type
Active Comparator
Arm Description
32 ounces orange soda
Intervention Type
Dietary Supplement
Intervention Name(s)
Orange soda
Intervention Description
32 ounces per day
Primary Outcome Measure Information:
Title
Change in urine citrate content
Description
Citrate is measured in 24h urine sample and expressed as mg/day
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Change in urine pH
Description
urine pH is measured in a 24h urine sample and has no units
Time Frame
One week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18-65 years old
able to sign consent
ability to reliably urinate into a vessel and measure urine volume
Exclusion Criteria:
prior history of nephrolithiasis
a known history of metabolic bone disease
hyperthyroidism
hyperparathyroidism or chronic kidney disease
current use of diuretics
current use of potassium citrate or other oral alkali supplementation and
use of calcium supplementation that could not be stopped
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Goldfarb, MD
Organizational Affiliation
New York Harbor VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Harbor VA Medical Center
City
New York City
State/Province
New York
ZIP/Postal Code
10010
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Diet Orange Soda on Urinary Lithogenicity
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