Status:
TERMINATED
Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Foundation for AIDS Research (CANFAR)
The Physicians' Services Incorporated Foundation
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
5-18 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- Known allergy to fish, soybean, or corn
- Current treatment with triglyceride-lowering agent
- Family history of familial hypertriglyceridemia
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00691288
Start Date
June 1 2008
End Date
December 1 2012
Last Update
June 12 2014
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada