- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01392313
Measurement of Renal Function With Iohexol in Subjects Ingesting Carnitine
July 19, 2018 updated by: Montefiore Medical Center
Measurement of Glomerular Filtration Rate (GFR) Using Iohexol in Healthy Subjects Taking Creatinine Supplements
The investigators will measure renal function in subjects ingesting carnitine to determine if the product alters renal function.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Bronx, New York, United States, 10467
- Montefiore Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- carnitine ingestion
Exclusion Criteria:
- renal disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Carnitine
Participants will be given Creatinine supplements
|
Carnitine Ingestion
|
Placebo Comparator: Placebo
participants will be given creatinine placebo
|
Carnitine placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Iohexol clearance
Time Frame: 1 month
|
Iohexol clearance will be measured
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joel Neugarten, MD, Montefiore Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Anticipated)
June 1, 2010
Study Completion (Anticipated)
June 1, 2010
Study Registration Dates
First Submitted
July 11, 2011
First Submitted That Met QC Criteria
July 11, 2011
First Posted (Estimate)
July 12, 2011
Study Record Updates
Last Update Posted (Actual)
July 23, 2018
Last Update Submitted That Met QC Criteria
July 19, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 10-03-068
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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