Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Terminated NCT01001585 - Anesthetic Effects in Mitochondrial Disease N/A
Completed NCT01642056 - EPI-743 for Metabolism or Mitochondrial Disorders Phase 1/Phase 2
Recruiting NCT04419870 - Acute Infection in Mitochondrial Disease: Metabolism, Infection and Immunity During the COVID19 Pandemic
Completed NCT00786539 - Mitochondria Inborn Errors of Metabolism and ANT Defects in Mitochondria Diseases
Active, not recruiting NCT02000284 - Mitochondrial Dysfunction in Autism Spectrum Disorder
Completed NCT04643249 - Drug-drug Interaction Study of KL1333 in Healthy Subjects Phase 1
Completed NCT02544217 - A Dose-escalating Clinical Trial With KH176 Phase 1
Completed NCT02154711 - Magnetic Resonance Imaging (MRI) Muscle Phenotyping in Mitochondrial Disease
Completed NCT01264471 - Mechanisms of Mitochondrial Defects in Gulf War Syndrome N/A
Completed NCT00829270 - Economic and Medical Evaluation of the Whole Mitochondrial DNA Screening by Surveyor and Mitochips Techniques N/A
Completed NCT02745938 - GDF-15 as a Biomarker for Mitochondrial Disease N/A
Enrolling by invitation NCT01803906 - Tissue Sample Study for Mitochondrial Disorders
Completed NCT01776918 - Energy Requirements in Mitochondrial Disease N/A
Completed NCT01301235 - Defining 31Phosphorous Magnetic Resonance Spectroscopy Characteristics in Patients With Mitochondrial Myopathy N/A
Completed NCT02985710 - Assessment of Small Fiber Neuropathy in Rare Diseases Using Sudoscan N/A
Recruiting NCT05241262 - Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels Phase 1
Completed NCT02678637 - Calf Muscle Strength in Mitochondrial Diseases N/A