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

This study has been terminated.

(Unable to enroll sufficient patients)

Sponsor:

Collaborators:

Canadian Foundation for AIDS Research (CANFAR)

The Physicians' Services Incorporated Foundation

Ocean Nutrition

Information provided by (Responsible Party):

Ari Bitnun, The Hospital for Sick Children

ClinicalTrials.gov Identifier:

NCT00691288

First received: May 27, 2008

Last updated: June 10, 2014

Last verified: June 2014

History of Changes

Purpose

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	Intervention	Phase
Hypertriglyceridemia	Drug: Omega Pure followed by placebo Drug: Placebo followed by Omega Pure	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Triglycerides

Drug Information available for: Omega-3 Fatty Acids

U.S. FDA Resources

Further study details as provided by Ari Bitnun, The Hospital for Sick Children:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]
Reporting of side effects, compliance, and discontinuation [ Time Frame: 4 and 12 weeks after beginning treatment ]
Effect on control of HIV (vial load, CD4) [ Time Frame: 12 weeks after beginning treatment ]


Enrollment:	13
Study Start Date:	June 2008
Study Completion Date:	December 2012
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00691288

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


Responsible Party:	Ari Bitnun, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00691288 History of Changes
Other Study ID Numbers:	1000011295
Study First Received:	May 27, 2008
Last Updated:	June 10, 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

ClinicalTrials.gov processed this record on May 25, 2017

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