NCT02311270

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

September 12, 2014

Last Update Submit

September 22, 2016

Conditions

Metabolic Disorders

Outcome Measures

Primary Outcomes (1)

  • Assess how many patients with metabolic disorders are on chronic carnitine supplementation.

    Up to one year from study activation.

Secondary Outcomes (1)

  • Assess how many patients who are on chronic carnitine supplementation have experienced a cardiovascular event.

    Up to one year from study activation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

  • Amel Karaa, MD

    Massachusetts General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

December 8, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

June 1, 2016

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

US(1)