Metabolic DisordersNCT02311270
Survey on Cardiovascular Events in Patients With Metabolic Disease on Chronic Carnitine Supplementation
An observational study of Metabolic Disorders, run by University of South Florida at 1 site in United States.
Trial summary
The purpose of this study is to learn about the effects of long term carnitine use in patients with metabolic disorders and its potential relationship to cardiovascular events. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disorders
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2016
- 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: All patients enrolled in the NAMDC portion of the RDCRN Contact Registry
Who may be able to join
- Diagnosis of mitochondrial disease or any other metabolic disorder
- Any age group
- NAMDC or RDCRN registry participant
Who cannot join
- Inability to provide informed consent and complete survey
- Lack of participation in NAMDC or RDCRN registry
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to learn about the effects of long term carnitine use in patients with metabolic disorders and its potential relationship to cardiovascular events.
Read the detailed description
This online cross-sectional survey will examine the self-reported long-term carnitine use in patients with metabolic disorders and any potential relationship to cardiovascular events.
- Conditions
- Metabolic Disorders
- Medical subject headings
- Metabolic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess how many patients with metabolic disorders are on chronic carnitine supplementation.
Measured: Up to one year from study activation.
Secondary outcomes (1)
Assess how many patients who are on chronic carnitine supplementation have experienced a cardiovascular event.
Measured: Up to one year from 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 completionSep 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DisordersStudies 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
- 106 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
- Amel Karaa, MD, Study chair, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311270
- Sponsor's protocol ID
- NAMDC7412
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2014
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey on Cardiovascular Events in Patients With Metabolic Disease on Chronic Carnitine Supplementation
- ClinicalTrials.gov ID
- NCT02311270
- Acronym / sponsor ID
- NAMDC7412
- Conditions
- Metabolic Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jun 2016 (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 effects of long term carnitine use in patients with metabolic disorders and its potential relationship to cardiovascular events.
Detailed description
This online cross-sectional survey will examine the self-reported long-term carnitine use in patients with metabolic disorders and any potential relationship to cardiovascular events.
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
- All patients enrolled in the NAMDC portion of the RDCRN Contact Registry
Key inclusion criteria (3 listed)
- Diagnosis of mitochondrial disease or any other metabolic disorder
- Any age group
- NAMDC or RDCRN registry participant
Key exclusion criteria (2 listed)
- Inability to provide informed consent and complete survey
- Lack of participation in NAMDC or RDCRN registry
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
Assess how many patients with metabolic disorders are on chronic carnitine supplementation.
Time frame: Up to one year from study activation.
1 secondary outcome
Assess how many patients who are on chronic carnitine supplementation have experienced a cardiovascular event.
Time frame: Up to one year from 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 23 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.
Amel Karaa, MD study chair
Massachusetts General Hospital
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 Metabolic Disorders, 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 3 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 23 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?
Assess how many patients with metabolic disorders are on chronic carnitine supplementation. (time frame: Up to one year from 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 23 Sep 2016.