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NCT02311270 Clinical Trial

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

Metabolic Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02311270
Other study ID # NAMDC7412
Secondary ID
Status Completed
Phase N/A
First received September 12, 2014
Last updated September 22, 2016
Start date September 2014
Est. completion date June 2016

Study information
Verified date September 2016
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date June 2016
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of South Florida Tampa Florida

Sponsors (2)
Lead Sponsor Collaborator
University of South Florida National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assess how many patients with metabolic disorders are on chronic carnitine supplementation. Up to one year from study activation. No
Secondary Assess how many patients who are on chronic carnitine supplementation have experienced a cardiovascular event. Up to one year from study activation No
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