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

Phase 2

Terminated

• Conditions: Hypertriglyceridemia
• Interventions: Drug: Omega Pure followed by placebo; Drug: Placebo followed by Omega Pure

• Registration Number: NCT00691288
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study First Submitted: 2008-05-27
• Study Start: 2008-06
• Study First Submitted QC: 2008-06-03
• Study First Posted: 2008-06-05
• Primary Completion: 2011-10
• Study Completion: 2012-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-10
• Last Update Posted: 2014-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Omega Pure followed by placebo	-
2	Placebo followed by Omega Pure	-

Primary Outcome Measures

Name	Time	Method
Percentage change in triglyceride levels	4 and 12 weeks after beginning treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada