Fish Oil Study for High Triglyceride Levels in Children
Fish Oil Treatment for Dyslipidemia Associated With Children and Adolescents
1 other identifier
interventional
42
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2009
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 8, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
May 7, 2014
CompletedNovember 8, 2022
October 1, 2022
3.2 years
June 4, 2009
April 4, 2014
October 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Triglyceride Level
after 8 week treatment or placebo period
Study Arms (2)
Omega-3-acid ethyl esters (Lovaza)
EXPERIMENTALThis 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 COMPARATORThis 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.
Interventions
Omega-3-acid ethyl esters (Lovaza), two 1-gram capsules taken twice daily for 8 weeks
Placebo (corn oil), two 1-gram capsules taken twice daily for 8 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Bleeding disorders
- Uncontrolled hypothyroidism
- Liver disease
- Allergy to fish/shellfish
- Patients requiring chronic use of aspirin and non-steroidal anti-inflammatory agents
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Babu Balagopallead
- GlaxoSmithKlinecollaborator
- Johns Hopkins Universitycollaborator
- Thomas Jefferson Universitycollaborator
Study Sites (3)
A. I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Thomas Jefferon University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Intrinsic variability of triglycerides is large and may have confounded analyses; 4-week washout between treatment periods may have been too short; a reduction of triglycerides in the corn oil placebo group may have compromised the results.
Results Point of Contact
- Title
- Research Coordinator
- Organization
- Nemours Alfred I. duPont Hospital for Children
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Gidding, MD
Nemours
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Research Scientist
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 8, 2009
Study Start
July 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
November 8, 2022
Results First Posted
May 7, 2014
Record last verified: 2022-10