Effect of Diet Orange Soda on Urinary Lithogenicity

Urolithiasis Clinical Trial

Official title:

Effect of Diet Orange Soda on Urinary Lithogenicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330940
• Other study ID #: 1100
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: September 6, 2012
• Start date: November 2009
• Est. completion date: July 2010

Study information

• Verified date: September 2012
• Source: VA New York Harbor Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stones
• Nephrolithiasis
• Urolithiasis

Intervention

Dietary Supplement:
• Orange soda
32 ounces per day

Locations

Country	Name	City	State
United States	New York Harbor VA Medical Center	New York City	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA New York Harbor Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urine citrate content	Citrate is measured in 24h urine sample and expressed as mg/day	1 week	No
Secondary	Change in urine pH	urine pH is measured in a 24h urine sample and has no units	One week	No