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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
  Purpose

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.


Condition Intervention
Kidney Stones
Nephrolithiasis
Urolithiasis
 Dietary Supplement: Orange soda

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effect of Diet Orange Soda on Urinary Lithogenicity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VA New York Harbor Healthcare System:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 12
Study Start Date: November 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Water drinking
32 ounces of water/24 hours
 Dietary Supplement: Orange soda
32 ounces per day
Active Comparator: orange soda drinking
32 ounces orange soda
 Dietary Supplement: Orange soda
32 ounces per day

Detailed Description:

The effect of orange soda compared with water in changing 24 hour urine citrate excretion in mg/day will be determined.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330940

Locations
United States, New York
New York Harbor VA Medical Center
New York City, New York, United States, 10010
Sponsors and Collaborators
VA New York Harbor Healthcare System
Investigators
Principal Investigator: David S Goldfarb, MD New York Harbor VA Medical Center
  More Information

No publications provided

Responsible Party: David S. Goldfarb, M.D., Chief, Nephrology, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier: NCT01330940     History of Changes
Other Study ID Numbers: 1100
Study First Received: April 4, 2011
Last Updated: September 6, 2012
Health Authority: United States: Federal Government

Keywords provided by VA New York Harbor Healthcare System:
Kidney stones
Calcium
citrate

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Urolithiasis
Kidney Diseases
 Urologic Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013