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

Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children Taking Highly Active Antiretroviral Therapy (HAART): a Randomized Cross-over Study

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.

Study Overview

• Status: Terminated
• Conditions: Hypertriglyceridemia
• Intervention / Treatment: Drug: Omega Pure followed by placebo; Drug: Placebo followed by Omega Pure

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1	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.; Other Names: omega-3 fatty acid supplementation
EXPERIMENTAL: 2	Drug: 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.; Other Names: Omega-3 fatty acid supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in triglyceride levels	4 and 12 weeks after beginning treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Foundation for AIDS Research (CANFAR); The Physicians' Services Incorporated Foundation; Ocean Nutrition
• Investigators: Principal Investigator: Ari Bitnun, MD, MSc, The Hospital for Sick Children; Principal Investigator: Jason Brophy, MD, The Hospital for Sick Children; Principal Investigator: Stanley Read, MD, PhD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: May 27, 2008
• First Submitted That Met QC Criteria: June 3, 2008
• First Posted (ESTIMATE): June 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 12, 2014
• Last Update Submitted That Met QC Criteria: June 10, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: HIV; pediatric; hypertriglyceridemia; omega-3 fatty acid; HAART
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertriglyceridemia
• Other Study ID Numbers: 1000011295