Effect of Diet Orange Soda on Urinary Lithogenicity

September 6, 2012 updated by: David S. Goldfarb, M.D., VA New York Harbor Healthcare System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York City, New York, United States, 10010
        • New York Harbor VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urine citrate content
Time Frame: 1 week
Citrate is measured in 24h urine sample and expressed as mg/day
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urine pH
Time Frame: One week
urine pH is measured in a 24h urine sample and has no units
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA New York Harbor Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (ESTIMATE)

April 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nephrolithiasis

Clinical Trials on Orange soda

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe