Survey on Supplement Use in Mitochondrial Disease

September 21, 2016 updated by: University of South Florida
The purpose of this study is to learn about the use of nutritional supplements in patients with mitochondrial disease.

Study Overview

Status

Completed

Conditions

Detailed Description

Our goal is to better assess which nutritional supplements are prescribed to patients with mitochondrial disorders, the monitoring obtained and whether any subjective improvements are noted by the patients or their caregivers.

Study Type

Observational

Enrollment (Actual)

162

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

Participants will be recruited through the NAMDC Clinical Registry and RDCRN Contact Registry. Additional means of recruitment may be used to direct patients to join the NAMDC or RDCRN registries.

Description

Inclusion Criteria:

  • NAMDC Clinical Registry or RDCRN Contact Registry participant
  • Diagnosis of a mitochondrial disease confirmed by either electron transport chain abnormalities or molecular testing.

Exclusion Criteria:

  • Lack of participation in NAMDC or RDCRN registries
  • Diagnosis of mitochondrial disorder not confirmed by ETC studies or molecular diagnosis

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
Measure Description
Time Frame
Assessment of nutritional supplement use in patients with mitochondrial disease.
Time Frame: Up to one year after study activation.
This cross-sectional survey will assess nutritional supplements used by patients with mitochondrial disease.
Up to one year after study activation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the attitudes of patients and parents towards use of nutritional supplements in patients with mitochondrial disease
Time Frame: Upt to one year after study activation.
This cross-sectional survey will assess patients' and parents' attitudes (comfort level and perceptions of efficacy) of use of nutritional supplements in patients with mitochondrial disease.
Upt to one year after 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: Michio Hirano, MD, Columbia University
  • Study Chair: Sumit Parikh, MD, The Cleveland Clinic
  • Study Chair: Amel Karaa, MD, Massachussetts 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)

December 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 21, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAMDC7411

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.

Clinical Trials on Mitochondrial Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe