NCT02311257

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

3 months

First QC Date

September 12, 2014

Last Update Submit

September 21, 2016

Conditions

Mitochondrial Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (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.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sumit Parikh, MD

    The Cleveland Clinic

    STUDY CHAIR

  • Amel Karaa, MD

    Massachussetts General Hospital

    STUDY CHAIR

  • Michio Hirano, MD

    Columbia University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2014

First Posted

December 8, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

US(1)