Clinical trial NCT00691288: Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children
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 Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Keywords: omega-3 fatty acid
hypertriglyceridemia
HIV
pediatric
HAART
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Canadian Foundation for AIDS Research (CANFAR)
name: The Physicians' Services Incorporated Foundation
name: Ocean Nutrition
First posted: 2008-06-05
Enrollment: 13
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage change in triglyceride levels
timeFrame: 4 and 12 weeks after beginning treatment
Secondary outcomes:
measure: Changes in cholesterol profiles (LDL, HDL, and total:HDL ratio), amylase, platelet function, AST, and ALT
timeFrame: 4 and 12 weeks after beginning treatment
measure: Reporting of side effects, compliance, and discontinuation
timeFrame: 4 and 12 weeks after beginning treatment
measure: Effect on control of HIV (vial load, CD4)
timeFrame: 12 weeks after beginning treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Ari Bitnun, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Jason Brophy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Stanley Read, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: