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Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children
This study has been terminated.
(Unable to enroll sufficient patients)
Sponsor:
The Hospital for Sick Children
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
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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:
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
|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00691288
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 July 26, 2017