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

NCT00691288 | Terminated Phase 2

• 1 other identifier: 1000011295
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertriglyceridemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage change in triglyceride levels

  4 and 12 weeks after beginning treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: Omega Pure followed by placebo

2

EXPERIMENTAL

Drug: Placebo followed by Omega Pure

Interventions

Omega Pure followed by placebo DRUG

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.

Also known as: omega-3 fatty acid supplementation

1

Placebo followed by Omega Pure DRUG

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.

Also known as: Omega-3 fatty acid supplementation

2

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to fish, soybean, or corn
• Current treatment with triglyceride-lowering agent
• Family history of familial hypertriglyceridemia

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Canadian Foundation for AIDS Research (CANFAR): collaborator
• The Physicians' Services Incorporated Foundation: collaborator
• Ocean Nutrition: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: June 5, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2012
• Last Updated: June 12, 2014

Record last verified: 2014-06

Locations

CA (1)