Effect of Hydroxycitrate on Urine Chemistry

NCT ID: NCT03348228

Last Updated: 2022-01-26

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2020-12-15

Brief Summary

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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

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Conditions

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Nephrolithiasis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

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

Group Type PLACEBO_COMPARATOR

Hydroxycitrate (HCA)

Intervention Type DIETARY_SUPPLEMENT

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).

Calcium Stone Formers

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

Group Type ACTIVE_COMPARATOR

Hydroxycitrate (HCA)

Intervention Type DIETARY_SUPPLEMENT

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).

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Goldfarb, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-00147

Identifier Type: -

Identifier Source: org_study_id

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