Back to resultsEffect of Hydroxycitrate on Urine Chemistry
Primary Purpose
Nephrolithiasis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hydroxycitrate (HCA)
Sponsored by
About this trial
This is an interventional treatment trial for Nephrolithiasis focused on measuring Hydroxycitrate Supplements
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:
-
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control Group
Calcium Stone Formers
Arm 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
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
Outcomes
Primary Outcome Measures
changes in urinary excretion of citrate
Paired t-tests will be performed to compare any changes in citrate before and after the intervention.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03348228
Brief Title
Effect of Hydroxycitrate on Urine Chemistry
Official Title
Effect of Hydroxycitrate on Urine Chemistry
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis
Keywords
Hydroxycitrate Supplements
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm 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 Title
Calcium Stone Formers
Arm Type
Active Comparator
Arm 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Hydroxycitrate (HCA)
Intervention 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).
Primary Outcome Measure Information:
Title
changes in urinary excretion of citrate
Description
Paired t-tests will be performed to compare any changes in citrate before and after the intervention.
Time Frame
7 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Goldfarb, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Hydroxycitrate on Urine Chemistry
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