Mitochondrial DiseaseNCT02311257
Survey on Supplement Use in Mitochondrial Disease
An observational study of Mitochondrial Disease, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of this study is to learn about the use of nutritional supplements in patients with mitochondrial disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Disease
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Mar 2015
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- NAMDC Clinical Registry or RDCRN Contact Registry participant
- Diagnosis of a mitochondrial disease confirmed by either electron transport chain abnormalities or molecular testing.
Who cannot join
- Lack of participation in NAMDC or RDCRN registries
- Diagnosis of mitochondrial disorder not confirmed by ETC studies or molecular diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to learn about the use of nutritional supplements in patients with mitochondrial disease.
Read the 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.
- Conditions
- Mitochondrial Disease
- Medical subject headings
- Mitochondrial Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of nutritional supplement use in patients with mitochondrial disease.
This cross-sectional survey will assess nutritional supplements used by patients with mitochondrial disease.
Measured: 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
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.
Measured: Upt to one year after study activation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial DiseaseStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 162 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sumit Parikh, MD, Study chair, The Cleveland ClinicAmel Karaa, MD, Study chair, Massachussetts General HospitalMichio Hirano, MD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311257
- Sponsor's protocol ID
- NAMDC7411
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2014
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Supplement Use in Mitochondrial Disease
- ClinicalTrials.gov ID
- NCT02311257
- Acronym / sponsor ID
- NAMDC7411
- Conditions
- Mitochondrial Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn about the use of nutritional supplements in patients with 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- NAMDC Clinical Registry or RDCRN Contact Registry participant
- Diagnosis of a mitochondrial disease confirmed by either electron transport chain abnormalities or molecular testing.
Key exclusion criteria (2 listed)
- Lack of participation in NAMDC or RDCRN registries
- Diagnosis of mitochondrial disorder not confirmed by ETC studies or molecular diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Rare Diseases Clinical Research Network NAMDC pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumit Parikh, MD study chair
The Cleveland Clinic
Amel Karaa, MD study chair
Massachussetts General Hospital
Michio Hirano, MD study chair
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitochondrial Disease, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of nutritional supplement use in patients with mitochondrial disease. (time frame: Up to one year after study activation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2016.