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Effect of Diet Orange Soda on Urinary Lithogenicity

NCT ID: NCT01330940

Last Updated: 2012-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Kidney Stones Nephrolithiasis Urolithiasis

Keywords

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Kidney stones Calcium citrate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Water drinking

32 ounces of water/24 hours

Group Type PLACEBO_COMPARATOR

Orange soda

Intervention Type DIETARY_SUPPLEMENT

32 ounces per day

orange soda drinking

32 ounces orange soda

Group Type ACTIVE_COMPARATOR

Orange soda

Intervention Type DIETARY_SUPPLEMENT

32 ounces per day

Interventions

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Orange soda

32 ounces per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA New York Harbor Healthcare System

FED

Sponsor Role lead

Responsible Party

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David S. Goldfarb, M.D.

Chief, Nephrology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David S Goldfarb, MD

Role: PRINCIPAL_INVESTIGATOR

New York Harbor VA Medical Center

Locations

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New York Harbor VA Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1100

Identifier Type: -

Identifier Source: org_study_id