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NCT02311257 Clinical Trial

Survey on Supplement Use in Mitochondrial Disease

Mitochondrial Disease Clinical Trial

Official title:
Survey on Supplement Use in Mitochondrial Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02311257
Other study ID # NAMDC7411
Secondary ID
Status Completed
Phase N/A
First received September 12, 2014
Last updated September 21, 2016
Start date September 2014
Est. completion date March 2015

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 use of nutritional supplements in patients with mitochondrial disease.

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.

Recruitment information / eligibility
Status Completed
Enrollment 162
Est. completion date March 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 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 Assessment of nutritional supplement use in patients with mitochondrial disease. This cross-sectional survey will assess nutritional supplements used by patients with mitochondrial disease. Up to one year after study activation. No
Secondary Assess the attitudes of patients and parents towards use of nutritional supplements in patients with mitochondrial disease 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. No
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