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OpenTrials
Completed

NCT Number: NCT01330940

Effect of Diet Orange Soda on Urinary Lithogenicity

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.

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Key information

Conditions

Kidney Stones Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Harbor VA Medical Center

New York, 10010, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orange soda

Dietary Supplement

32 ounces per day

Primary outcomes

  1. Change in urine citrate content

    Time frame: 1 week

    Citrate is measured in 24h urine sample and expressed as mg/day

Secondary outcomes

  1. Change in urine pH

    Time frame: One week

    urine pH is measured in a 24h urine sample and has no units

Sponsors and collaborators

Lead sponsor

VA New York Harbor Healthcare System

Fed

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 7, 2011
Registry last updated
Sep 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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