Hypertriglyceridemia
Conditions
Keywords
omega-3 fatty acid, hypertriglyceridemia, HIV, pediatric, HAART
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 description
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.
Interventions
DRUGOmega Pure followed by placebo
Subjects in this arm will begin the study on active capsules (containing Omega Pure). Subjects in the 5-11 age group will take 2 capsules containing 500mg EPA/DHA twice daily for 12 weeks. Subjects in the 12-18 age group will take 2 capsules containing 1.0g EPA/DHA twice daily, also for a period of 12 weeks. Both age groups will then be switched to the placebo capsules containing citrus-flavoured soybean and corn oil, identical in appearance to the active agent, to be taken on an identical regimen to the active pills, for a period of 12 weeks.
DRUGPlacebo followed by Omega Pure
Patients assigned to this arm of the study will begin on placebo followed by Omega Pure (identical dose and regimen as arm 1), also for a period of 12 weeks each.
Sponsors
Canadian Foundation for AIDS Research (CANFAR)
The Physicians' Services Incorporated Foundation
Ocean Nutrition
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* HIV positive children aged 5-18 years on stable HAART therapy for at least 6 months, with reasonable control of their HIV (viral load remaining undetectable, or stable with \<0.5 log increase in previous 3-4 months) and no plans for a change in therapy in the next year * Elevated fasting triglyceride level \>1.5 mmol/L on at least two occasions within the previous year (including at least one in the last 3 months while on the current HAART regimen) * Ability to swallow capsules
Exclusion criteria
* Known allergy to fish, soybean, or corn * Current treatment with triglyceride-lowering agent * Family history of familial hypertriglyceridemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in triglyceride levels | 4 and 12 weeks after beginning treatment |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cholesterol profiles (LDL, HDL, and total:HDL ratio), amylase, platelet function, AST, and ALT | 4 and 12 weeks after beginning treatment |
| Reporting of side effects, compliance, and discontinuation | 4 and 12 weeks after beginning treatment |
| Effect on control of HIV (vial load, CD4) | 12 weeks after beginning treatment |
Countries
Canada
Outcome results
None listed