Clinical Trial: Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children Taking Highly Active Antiretroviral Therapy (HAART): a Randomized Cross-over

Brief Summary: The overall objective of this study is to evaluate the safety and efficacy of fish oil omega-3-fatty acid supplementation in treating pediatric HAART-associated hypertriglyceridemia.

Detailed Summary:

There are no guidelines as to the clinical threshold at which treatment for hypertriglyceridemia is necessary in pediatric populations, and extreme hypertriglyceridemia is relatively infrequent in HIV-infected children. Adult studies have suggested that there is a proportionate reduction in triglycerides of approximately 15-25% when taking fish oil omega-3 fatty acid supplementation, irrespective of the degree of initial triglyceride elevation. This trial would thus represent a proof-of-concept study in children with mild to moderate hypertriglyceridemia.

The results of this study would contribute to the pool of knowledge regarding the efficacy and safety of this nutriceutical in the treatment of HAART-associated hypertriglyceridemia in children. Compared with other interventions (such as dietary changes and drug therapies), nutritional supplementation with fish oil is an inexpensive, simple, and likely preferable treatment for a potentially significant medical condition. In addition, the results of this study could presumably be extrapolated to benefit children with hypertriglyceridemia secondary to other types of drugs or illnesses.


Sponsor: The Hospital for Sick Children

Current Primary Outcome: Percentage change in triglyceride levels [ Time Frame: 4 and 12 weeks after beginning treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in cholesterol profiles (LDL, HDL, and total:HDL ratio), amylase, platelet function, AST, and ALT [ Time Frame: 4 and 12 weeks after beginning treatment ]
  • Reporting of side effects, compliance, and discontinuation [ Time Frame: 4 and 12 weeks after beginning treatment ]
  • Effect on control of HIV (vial load, CD4) [ Time Frame: 12 weeks after beginning treatment ]


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: May 27, 2008
Date Started: June 2008
Date Completion:
Last Updated: June 10, 2014
Last Verified: June 2014