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

Hypertriglyceridemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00691288
• Other study ID #: 1000011295
• Status: Terminated
• Phase: Phase 2
• First received: May 27, 2008
• Last updated: June 10, 2014
• Start date: June 2008
• Est. completion date: December 2012

Study information

• Verified date: June 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• Omega Pure followed by placebo
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.
• Placebo followed by Omega Pure
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Foundation for AIDS Research (CANFAR), Ocean Nutrition, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in triglyceride levels		4 and 12 weeks after beginning treatment	No
Secondary	Changes in cholesterol profiles (LDL, HDL, and total:HDL ratio), amylase, platelet function, AST, and ALT		4 and 12 weeks after beginning treatment	No
Secondary	Reporting of side effects, compliance, and discontinuation		4 and 12 weeks after beginning treatment	No
Secondary	Effect on control of HIV (vial load, CD4)		12 weeks after beginning treatment	No