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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hypertriglyceridemia

Intervention / Treatment
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* Drug: Omega Pure followed by placebo
* Drug: Placebo followed by Omega Pure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Omega Pure followed by placebo<br>* 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.<br>* Other names: omega-3 fatty acid supplementation;|
| Experimental: 2<br> | Drug: Placebo followed by Omega Pure<br>* 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.<br>* Other names: Omega-3 fatty acid supplementation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change in triglyceride levels |  | 4 and 12 weeks after beginning treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3 fatty acid, hypertriglyceridemia, HIV, pediatric, HAART