HyperlipidemiaPhase 1EARLYMeditNCT01308710
The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia
A Phase 1 study testing Omega-3 fatty acid (Eicosapentaenoic acid) in people with Hyperlipidemia, run by University of California, San Francisco at 1 site in United States.
Trial summary
Children with high cholesterol levels are especially vulnerable and are at high risk for early onset coronary heart disease (CHD). Endothelial dysfunction, the earliest phase of CHD, is present in children with elevated cholesterol levels as early as 8 years of age. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Omega-3 fatty acid (Eicosapentaenoic acid)
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2011
- Phase
- Phase 1
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (8-17 years old)
- Familial Hypercholesterolemia or Familial Combined Hyperlipidemia
- Able to read, write and understand English
- Parental consent and child assent
- Access to a computer and internet and literacy in the use of the internet
- The attendance of a parent to each educational session.
Who cannot join
- Chronic systemic illness with or without secondary hyperlipidemia
- Current smoking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet
Children with high cholesterol levels are especially vulnerable and are at high risk for early onset coronary heart disease (CHD). Endothelial dysfunction, the earliest phase of CHD, is present in children with elevated cholesterol levels as early as 8 years of age. The long term objective of this study is to develop dietary interventions for the prevention and treatment of endothelial dysfunction in children with common lipid disorders including familial hypercholesterolemia (FH) and familial combined hyperlipidemia (FCH). Increasing evidence suggests that the Mediterranean diet and ω-3 fatty acids found in fish have cardioprotective effects. The specific aims of the study are to: determine whether a Mediterranean diet alone or combined with ω-3 fatty acid (eicosapentaenoic acid)improves endothelial function; evaluate the effects of the dietary interventions on lipids and lipoprotein subclasses; evaluate the effects of the dietary interventions on biomarkers for oxidative stress and inflammation. This study is a randomized, double-blind, placebo-controlled clinical trial that includes 34 children (ages 8-17) treated with the Mediterranean diet and ω-3 fatty acid supplements. A dietary educational behavioral intervention will be conducted over 6 months with individual counseling and group sessions. Endothelial function will be measured noninvasively by high resolution ultrasound of the brachial artery at baseline, 6, 12, 18 and 24 weeks. This study is unique because it is a new intervention designed for children at high risk for early CHD with a dietary component and supplementation with ω-3 fatty acids. If effective, this intervention would be broadly applicable in the community and lend valuable insight about dietary therapy to prevent the progression of CHD in hyperlipidemic children.
- Conditions
- Hyperlipidemia
- Being tested
- Omega-3 fatty acid (Eicosapentaenoic acid)
- Keywords
- endothelial function, lipids, pediatrics
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acid (Eicosapentaenoic acid)Dietary supplement
Also called PlusEPA
1.0 grams daily for 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Measured: Measured every 6 wks for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University, Tufts University, University of Guelph, University of L'Aquila
- Responsible party
- Sponsor
- Investigators
- Marguerite M. Engler, PhD, Principal investigator, University of California, San FranciscoMary B. Engler, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308710
- Sponsor's protocol ID
- R56NR004909
- Acronym
- EARLYMedit
- Status last verified
- Jan 2014
- First submitted
- 3 Mar 2011
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Assessment of Risk From Lipids in Youth: Mediterranean Diet
- ClinicalTrials.gov ID
- NCT01308710
- Acronym / sponsor ID
- EARLYMedit / R56NR004909
- Conditions
- Hyperlipidemia
- Keywords
- endothelial function, lipids, pediatrics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Vanderbilt University, Tufts University, University of Guelph, University of L'Aquila
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Mar 2011 (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.
Children with high cholesterol levels are especially vulnerable and are at high risk for early onset coronary heart disease (CHD). Endothelial dysfunction, the earliest phase of CHD, is present in children with elevated cholesterol levels as early as 8 years of age. The long term objective of this study is to develop dietary interventions for the prevention and treatment of endothelial dysfunction in children with common lipid disorders including familial hypercholesterolemia (FH) and familial combined hyperlipidemia (FCH). Increasing evidence suggests that the Mediterranean diet and ω-3 fatty acids found in fish have cardioprotective effects. The specific aims of the study are to: determine whether a Mediterranean diet alone or combined with ω-3 fatty acid (eicosapentaenoic acid)improves endothelial function; evaluate the effects of the dietary interventions on lipids and lipoprotein subclasses; evaluate the effects of the dietary interventions on biomarkers for oxidative stress and inflammation. This study is a randomized, double-blind, placebo-controlled clinical trial that includes 34 children (ages 8-17) treated with the Mediterranean diet and ω-3 fatty acid supplements. A dietary educational behavioral intervention will be conducted over 6 months with individual counseling and group sessions. Endothelial function will be measured noninvasively by high resolution ultrasound of the brachial artery at baseline, 6, 12, 18 and 24 weeks. This study is unique because it is a new intervention designed for children at high risk for early CHD with a dietary component and supplementation with ω-3 fatty acids. If effective, this intervention would be broadly applicable in the community and lend valuable insight about dietary therapy to prevent the progression of CHD in hyperlipidemic children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children (8-17 years old)
- Familial Hypercholesterolemia or Familial Combined Hyperlipidemia
- Able to read, write and understand English
- Parental consent and child assent
- Access to a computer and internet and literacy in the use of the internet
Key exclusion criteria (2 listed)
- Chronic systemic illness with or without secondary hyperlipidemia
- Current smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acid (Eicosapentaenoic acid)Also: PlusEPA1.0 grams daily for 6 weeks | Dietary supplement | – |
Primary outcome
Endothelial function
Time frame: Measured every 6 wks for 6 months
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 27 Jan 2014.
Related trials for Hyperlipidemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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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.
Marguerite M. Engler, PhD principal investigator
University of California, San Francisco
Mary B. Engler, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega-3 fatty acid (Eicosapentaenoic acid) in people with Hyperlipidemia, run by University of California, San Francisco 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 6 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 27 Jan 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Endothelial function (time frame: Measured every 6 wks for 6 months). 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 27 Jan 2014.