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Survey on Supplement Use in Mitochondrial Disease

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ClinicalTrials.gov Identifier: NCT02311257
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of South Florida

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

Condition or disease
Mitochondrial Disease

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 162 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Survey on Supplement Use in Mitochondrial Disease
Study Start Date : September 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311257


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
National Institutes of Health (NIH)
Investigators
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Study Chair: Sumit Parikh, MD The Cleveland Clinic
Study Chair: Amel Karaa, MD Massachussetts General Hospital
Study Chair: Michio Hirano, MD Columbia University
Additional Information:
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02311257    
Other Study ID Numbers: NAMDC7411
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Mitochondrial Diseases
Metabolic Diseases