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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hypertriglyceridemia	Drug: Omega Pure followed by placebo; Drug: Placebo followed by Omega Pure	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	13 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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 Start Date :	June 2008
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	December 2012

Arms and Interventions

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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 Name: 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 Name: Omega-3 fatty acid supplementation

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Percentage change in triglyceride levels [ Time Frame: 4 and 12 weeks after beginning treatment ]

Secondary Outcome Measures :

1. Changes in cholesterol profiles (LDL, HDL, and total:HDL ratio), amylase, platelet function, AST, and ALT [ Time Frame: 4 and 12 weeks after beginning treatment ]
2. Reporting of side effects, compliance, and discontinuation [ Time Frame: 4 and 12 weeks after beginning treatment ]
3. Effect on control of HIV (vial load, CD4) [ Time Frame: 12 weeks after beginning treatment ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	5 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

The Hospital for Sick Children

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ari Bitnun, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00691288 History of Changes
Other Study ID Numbers:	1000011295
First Posted:	June 5, 2008
Last Update Posted:	June 12, 2014
Last Verified:	June 2014

Keywords provided by Ari Bitnun, The Hospital for Sick Children:

omega-3 fatty acid; hypertriglyceridemia; HIV; pediatric; HAART

Additional relevant MeSH terms:

Hypertriglyceridemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases