Phase 3
N=42
Fish Oil Study for High Triglyceride Levels in Children
Hypertriglyceridemia
Bottom Line
View on ClinicalTrials.gov: NCT00915902 ↗Enrolled (actual)
42
Serious AEs
1.2%
Results posted
May 2014
Primary outcome: Primary: Change in Triglyceride Level — -52; -16 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omega-3-acid ethyl esters (Drug); Placebo (Drug)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Babu Balagopal
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Triglyceride Level |
-52; -16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female patients who are 10-17 years of age
- Fasting triglyceride level >150 mg/dl and 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
Data sourced from ClinicalTrials.gov (NCT00915902). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.