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Effect of Diet Orange Soda on Urinary Lithogenicity

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ClinicalTrials.gov Identifier: NCT01330940
Recruitment Status : Completed
First Posted : April 7, 2011
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
David S. Goldfarb, M.D., VA New York Harbor Healthcare System

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.

Condition or disease Intervention/treatment Phase
Kidney Stones Nephrolithiasis Urolithiasis Dietary Supplement: Orange soda Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Diet Orange Soda on Urinary Lithogenicity
Study Start Date : November 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change in urine citrate content [ Time Frame: 1 week ]
    Citrate is measured in 24h urine sample and expressed as mg/day


Secondary Outcome Measures :
  1. Change in urine pH [ Time Frame: One week ]
    urine pH is measured in a 24h urine sample and has no units



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 7, 2011    Key Record Dates
Last Update Posted: September 10, 2012
Last Verified: September 2012

Keywords provided by David S. Goldfarb, M.D., 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