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NCT03348228 Clinical Trial

Effect of Hydroxycitrate on Urine Chemistry

Nephrolithiasis Clinical Trial

Official title:
Effect of Hydroxycitrate on Urine Chemistry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03348228
Other study ID # 17-00147
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 4, 2018
Est. completion date December 15, 2020

Study information
Verified date January 2022
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date December 15, 2020
Est. primary completion date December 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Hydroxycitrate (HCA)
Hydroxycitrate supplements are available over the counter and are primarily promoted as a weight loss supplement. Each subject will be given 42 capsules of Swanson super citrimax (hydroxycitrate) Details of the product are provided above. The subjects will be asked to take the capsules over a seven period (6 capsules per day).

Locations
Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)
Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary changes in urinary excretion of citrate Paired t-tests will be performed to compare any changes in citrate before and after the intervention. 7 Days
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