HypertriglyceridemiaPhase 2/3NCT00915902
Fish Oil Study for High Triglyceride Levels in Children
A Phase 2/3 study testing Omega-3-acid ethyl esters in people with Hypertriglyceridemia, run by Babu Balagopal at 3 sites in United States.
Trial summary
High triglyceride levels are increasingly recognized in children, particularly those who are overweight. There are no studies of treatment of high triglycerides in children and adolescents. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Omega-3-acid ethyl esters
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Sep 2012
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female patients who are 10-17 years of age
- Fasting triglyceride level >150 mg/dl and < 750 mg/dl measured on 2 separate occasions.
- Ability to follow the study procedures and adhere to the diet counseling recommendations
- Written parental permission and assent are obtained prior to any research procedures
Who cannot join
- Bleeding disorders
- Diabetes mellitus (impaired glucose tolerance is not an exclusion)
- Uncontrolled hypothyroidism
- Liver disease
- Allergy to fish/shellfish
- Patients requiring chronic use of aspirin and non-steroidal anti-inflammatory agents
Show all 12Show fewer
- Patients requiring lipid lowering agents
- LDL-Cholesterol levels >160 mg/dl
- Current participation in another clinical study or within the previous 30 days
- Alcohol use
- Currently pregnant or planning to become pregnant during the course of this trial (confirmed by pregnancy testing)
- Any significant medical condition which the investigator believes would interfere with the patient's ability to safely participate in this trial
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Thomas Jefferon University
Philadelphia, Pennsylvania, 19107
A. I. duPont Hospital for Children
Wilmington, Delaware, 19803
About this study
Official title: Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents
High triglyceride levels are increasingly recognized in children, particularly those who are overweight. There are no studies of treatment of high triglycerides in children and adolescents. Fish oil is attractive because it is considered safe and effective for treating high triglycerides in adults and has been used safely for other purposes in children. The investigators will conduct a randomized study of Lovaza (the only prescription omega-3 fish oil medication) in 44 children and adolescents to study efficacy in lowering triglycerides, safety, and possible mechanisms of beneficial effects.
Read the detailed description
Participants (n = 42, age 14 + 2 yrs) with hypertriglyceridemia and LDL cholesterol < 160 mg/dl were enrolled in a randomized double blind cross over trial comparing 4 g fish oil daily with placebo. Treatment interval was 8 weeks with a 4 week wash out, between the two treatment intervals. Lipid profile, lipoprotein particle distribution and size, glucose, insulin, high sensitivity C reactive protien (CRP), interleukin-6, fibrinogen, plasminogen activator inhibitor-1 (PAI-1), and thrombin generation were measured.
Patients were evaluated at 6 time points: Visit 1/baseline (week 0), Visit 2/randomization (week 4), Visit 3/after treatment 1 (week 12) , Visit 4/after wash out (week 16), Visit 5/after treatment 2 (week 24) and Visit 6/close out (week 28) . Patients were advised to maintain a stable diet and not alter baseline fish consumption . One participant took an oral contraceptive throughout the trial. Any fish oil supplements were discontinued. Advice on a heart healthy diet was provided. Blood pressure (right arm sitting with appropriate sized cuff, taken 3 times, last measurement used), height, and weight were measured at the beginning of the study, after the first wash out period, and close out. Participant phone contact was made during each treatment arm to assess diet stability. Fasting lipid profile was performed at every visit. Red blood cell fatty acid profile and secondary endpoints were performed at all visits except baseline.
- Conditions
- Hypertriglyceridemia
- Being tested
- Omega-3-acid ethyl esters, Placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3-acid ethyl estersDrug
Also called Lovaza
Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks
PlaceboDrug
Also called Corn Oil
Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Omega-3-acid ethyl esters (Lovaza) | Experimental | This randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. GlaxoSmithKline supplied the study drug and the placebo. The study drug, Omega-3-acid ethyl esters (Lovaza) was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week treatment period. The study drug contained minimally 1.5 g DHA (docosahexaenoic acid) and 1.86 g EPA (eicosapentaenoic acid). Receives: Drug: Omega-3-acid ethyl esters |
| Placebo | Placebo comparator | This randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. The corn oil placebo was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week non-treatment (placebo) period. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Triglyceride Level
Measured: after 8 week treatment or placebo period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Babu Balagopal
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Johns Hopkins University, Thomas Jefferson University
- Responsible party
- Sponsor-investigator, Babu Balagopal, Nemours Children's Clinic
- Investigators
- Samuel Gidding, MD, Principal investigator, Nemours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915902
- Sponsor's protocol ID
- GIDDING
- Status last verified
- Oct 2022
- First submitted
- 4 Jun 2009
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents
- ClinicalTrials.gov ID
- NCT00915902
- Acronym / sponsor ID
- GIDDING
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Babu BalagopalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Johns Hopkins University, Thomas Jefferson University
- Study start
- Jul 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 8 Jun 2009 (estimated)
- Results
- Posted 7 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High triglyceride levels are increasingly recognized in children, particularly those who are overweight. There are no studies of treatment of high triglycerides in children and adolescents. Fish oil is attractive because it is considered safe and effective for treating high triglycerides in adults and has been used safely for other purposes in children. The investigators will conduct a randomized study of Lovaza (the only prescription omega-3 fish oil medication) in 44 children and adolescents to study efficacy in lowering triglycerides, safety, and possible mechanisms of beneficial effects.
Detailed description
Participants (n = 42, age 14 + 2 yrs) with hypertriglyceridemia and LDL cholesterol < 160 mg/dl were enrolled in a randomized double blind cross over trial comparing 4 g fish oil daily with placebo. Treatment interval was 8 weeks with a 4 week wash out, between the two treatment intervals. Lipid profile, lipoprotein particle distribution and size, glucose, insulin, high sensitivity C reactive protien (CRP), interleukin-6, fibrinogen, plasminogen activator inhibitor-1 (PAI-1), and thrombin generation were measured.
Patients were evaluated at 6 time points: Visit 1/baseline (week 0), Visit 2/randomization (week 4), Visit 3/after treatment 1 (week 12) , Visit 4/after wash out (week 16), Visit 5/after treatment 2 (week 24) and Visit 6/close out (week 28) . Patients were advised to maintain a stable diet and not alter baseline fish consumption . One participant took an oral contraceptive throughout the trial. Any fish oil supplements were discontinued. Advice on a heart healthy diet was provided. Blood pressure (right arm sitting with appropriate sized cuff, taken 3 times, last measurement used), height, and weight were measured at the beginning of the study, after the first wash out period, and close out. Participant phone contact was made during each treatment arm to assess diet stability. Fasting lipid profile was performed at every visit. Red blood cell fatty acid profile and secondary endpoints were performed at all visits except baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3-acid ethyl esters (Lovaza) | Experimental | Drug: Omega-3-acid ethyl estersThis randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. GlaxoSmithKline supplied the study drug and the placebo. The study drug, Omega-3-acid ethyl esters (Lovaza) was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week treatment period. The study drug contained minimally 1.5 g DHA (docosahexaenoic acid) and 1.86 g EPA (eicosapentaenoic acid). |
| Placebo | Placebo comparator | Drug: PlaceboThis randomized, double-blind, placebo, crossover trial consisted of two 8-week treatment periods, separated by a 4-week washout. Eligible patients were randomized to receive either fish oil 4 g daily or corn oil placebo during the first 8-week treatment period; patients received the alternate treatment during the next treatment period. The corn oil placebo was given to patients PO daily as two, 1 g capsules taken twice daily during the duration of their 8-week non-treatment (placebo) period. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female patients who are 10-17 years of age
- Fasting triglyceride level >150 mg/dl and < 750 mg/dl measured on 2 separate occasions.
- Ability to follow the study procedures and adhere to the diet counseling recommendations
- Written parental permission and assent are obtained prior to any research procedures
Key exclusion criteria (12 listed)
- Bleeding disorders
- Diabetes mellitus (impaired glucose tolerance is not an exclusion)
- Uncontrolled hypothyroidism
- Liver disease
- Allergy to fish/shellfish
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-acid ethyl estersAlso: LovazaOmega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks | Drug | Omega-3-acid ethyl esters (Lovaza) |
| PlaceboAlso: Corn OilPlacebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks | Drug | Placebo |
Primary outcome
Change in Triglyceride Level
Time frame: after 8 week treatment or placebo period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Samuel Gidding, MD principal investigator
Nemours
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Omega-3-acid ethyl esters in people with Hypertriglyceridemia, run by Babu Balagopal at 3 sites 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 4 inclusion and 12 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Triglyceride Level (time frame: after 8 week treatment or placebo period). 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 8 Nov 2022.