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

NCT00691288 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2014-06-12

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Canadian Foundation for AIDS Research (CANFAR)

    collaborator OTHER

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Ocean Nutrition

    collaborator INDUSTRY

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Ari Bitnun, MD, MSc · The Hospital for Sick Children

  • Jason Brophy, MD · The Hospital for Sick Children

  • Stanley Read, MD, PhD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-10-31
Completion
2012-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00691288 on ClinicalTrials.gov