Effect of Hydroxycitrate on Urine Chemistry

Effect of Hydroxycitrate on Urine Chemistry

Sponsors

Lead sponsor: NYU Langone Health

Source 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.

Overall Status Recruiting
Start Date October 4, 2018
Completion Date March 2020
Primary Completion Date March 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
changes in urinary excretion of citrate 7 Days
Enrollment 40
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Hydroxycitrate (HCA)

Description: 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).

Eligibility

Criteria:

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:

-

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
David Goldfarb, MD Principal Investigator NYU Langone Health
Overall Contact

Last name: David Goldfarb

Phone: 212 263 0744

Email: [email protected]

Location
facility status contact investigator New York University School of Medicine David Goldfarb, MD 212-263-0744 [email protected] David Goldfarb, MD Principal Investigator
Location Countries

United States

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control Group

Arm group type: Placebo Comparator

Description: 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

Arm group label: Calcium Stone Formers

Arm group type: Active Comparator

Description: 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

Patient Data Undecided
Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov