Fish Oil Study for High Triglyceride Levels in Children
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Hypertriglyceridemia
In brief
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.
Key facts
- Study ID
- NCT00915902
- Run by
- Babu Balagopal
- People needed
- 42
- Starts
- 2009-07-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2022-11-08
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
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
- 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
- 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
Where it is running
- A. I. duPont Hospital for Children — Wilmington, Delaware, United States
- Johns Hopkins Hospital — Baltimore, Maryland, United States
- Thomas Jefferon University — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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