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Survey on Supplement Use in Mitochondrial Disease

Sponsor
University of South Florida (Other)
Overall Status
Completed
CT.gov ID
NCT02311257
Collaborator
National Institutes of Health (NIH) (NIH)
162
Enrollment
1
Location
5.9
Duration (Months)
27.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to learn about the use of nutritional supplements in patients with mitochondrial disease.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    162 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Survey on Supplement Use in Mitochondrial Disease
    Study Start Date :
    Sep 1, 2014
    Actual Primary Completion Date :
    Dec 1, 2014
    Actual Study Completion Date :
    Mar 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Assessment of nutritional supplement use in patients with mitochondrial disease. [Up to one year after study activation.]

      This cross-sectional survey will assess nutritional supplements used by patients with mitochondrial disease.

    Secondary Outcome Measures

    1. Assess the attitudes of patients and parents towards use of nutritional supplements in patients with mitochondrial disease [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Florida Tampa Florida United States 33612

    Sponsors and Collaborators

    • University of South Florida
    • National Institutes of Health (NIH)

    Investigators

    • Study Chair: Sumit Parikh, MD, The Cleveland Clinic
    • Study Chair: Amel Karaa, MD, Massachussetts General Hospital
    • Study Chair: Michio Hirano, MD, Columbia University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    University of South Florida
    ClinicalTrials.gov Identifier:
    NCT02311257
    Other Study ID Numbers:
    • NAMDC7411
    First Posted:
    Dec 8, 2014
    Last Update Posted:
    Sep 22, 2016
    Last Verified:
    Sep 1, 2016
    Additional relevant MeSH terms:
    Mitochondrial Diseases

    Study Results

    No Results Posted as of Sep 22, 2016