Effect of Hydroxycitrate on Urine Chemistry

Not Applicable

Completed

• Conditions: Nephrolithiasis
• Interventions: Dietary Supplement: Hydroxycitrate (HCA)

• Registration Number: NCT03348228
• Lead Sponsor: NYU Langone Health

Brief Summary

Hydroxycitrate (HCA) is a compound extracted from the fruit, Garcinia Cambogia. Hydroxycitrate supplements are available over the counter and are primarily promoted as a weight loss supplement. There has been recent evidence that hydroxycitrate is a potent inhibitor of calcium oxalate crystal growth and can lead to the dissolution of the crystals. The purpose of this research study is to study the effect of Hydroxycitrate (HCA) supplements on HCA urinary excretion and on urine chemistries in kidney stone formers and normal subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Study Start: 2018-10-04
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-11
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Stone formers group:

• Established diagnosis of recurrent calcium stone formers
• Ages between 18 and 80
• Subjects must be able to read and follow instructions clearly and able to do 24 hour urine collections.
• Subjects must be voluntarily willing and able to sign an informed consent form.

Control Group:

• In addition to b, c and d above, subjects must not have any known kidney disease or family history of renal stones. Inclusion would be based on information provided by participants.

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Hydroxycitrate (HCA)	Participants willrecord a self-selected diet for 3 days and then perform two 24-hour urine collections on the last 2 days of this diet. HCA will be administered afterwards to both groups (see methods below) for 7 days
Calcium Stone Formers	Hydroxycitrate (HCA)	Participants willrecord a self-selected diet for 3 days and then perform two 24-hour urine collections on the last 2 days of this diet. HCA will be administered afterwards to both groups (see methods below) for 7 days

Primary Outcome Measures

Name	Time	Method
changes in urinary excretion of citrate	7 Days	Paired t-tests will be performed to compare any changes in citrate before and after the intervention.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States