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

The Hospital for Sick Children

Status and phase: Terminated; Phase 2

Conditions: Hypertriglyceridemia

Treatments: Drug: Omega Pure followed by placebo; Drug: Placebo followed by Omega Pure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00691288

1000011295

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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13 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Omega Pure followed by placebo

2

Experimental group

Treatment:

Drug: Placebo followed by Omega Pure