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Effect of Diet Orange Soda on Urinary Lithogenicity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David S. Goldfarb, M.D., VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier:
NCT01330940
First received: April 4, 2011
Last updated: September 6, 2012
Last verified: September 2012
History of Changes

April 4, 2011
September 6, 2012
November 2009
July 2010   (final data collection date for primary outcome measure)
Change in urine citrate content [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Citrate is measured in 24h urine sample and expressed as mg/day
Change in urine citrate content [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01330940 on ClinicalTrials.gov Archive Site
Change in urine pH [ Time Frame: One week ] [ Designated as safety issue: No ]
urine pH is measured in a 24h urine sample and has no units
Change in urine pH [ Time Frame: One week ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Effect of Diet Orange Soda on Urinary Lithogenicity
Effect of Diet Orange Soda on Urinary Lithogenicity

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.

The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Kidney Stones
  • Nephrolithiasis
  • Urolithiasis
Dietary Supplement: Orange soda
32 ounces per day
  • Placebo Comparator: Water drinking
    32 ounces of water/24 hours
    Intervention: Dietary Supplement: Orange soda
  • Active Comparator: orange soda drinking
    32 ounces orange soda
    Intervention: Dietary Supplement: Orange soda
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01330940
1100
No
David S. Goldfarb, M.D., VA New York Harbor Healthcare System
VA New York Harbor Healthcare System
Not Provided
Principal Investigator: David S Goldfarb, MD New York Harbor VA Medical Center
VA New York Harbor Healthcare System
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP