Survey on Cardiovascular Events in Patients With Metabolic Disease on Chronic Carnitine Supplementation

September 22, 2016 updated by: University of South Florida
The purpose of this study is to learn about the effects of long term carnitine use in patients with metabolic disorders and its potential relationship to cardiovascular events.

Study Overview

Status

Completed

Conditions

Detailed Description

This online cross-sectional survey will examine the self-reported long-term carnitine use in patients with metabolic disorders and any potential relationship to cardiovascular events.

Study Type

Observational

Enrollment (Actual)

106

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

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • University of South Florida

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients enrolled in the NAMDC portion of the RDCRN Contact Registry

Description

Inclusion Criteria:

  • Diagnosis of mitochondrial disease or any other metabolic disorder
  • Any age group
  • NAMDC or RDCRN registry participant

Exclusion Criteria:

  • Inability to provide informed consent and complete survey
  • Lack of participation in NAMDC or RDCRN registry

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess how many patients with metabolic disorders are on chronic carnitine supplementation.
Time Frame: Up to one year from study activation.
Up to one year from study activation.

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess how many patients who are on chronic carnitine supplementation have experienced a cardiovascular event.
Time Frame: Up to one year from study activation
Up to one year from study activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Collaborators

National Institutes of Health (NIH)

Investigators

  • Study Chair: Amel Karaa, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

September 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAMDC7412

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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