Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children
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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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 |
- Percentage change in triglyceride levels [ Time Frame: 4 and 12 weeks after beginning treatment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Reporting of side effects, compliance, and discontinuation [ Time Frame: 4 and 12 weeks after beginning treatment ] [ Designated as safety issue: No ]
- Effect on control of HIV (vial load, CD4) [ Time Frame: 12 weeks after beginning treatment ] [ Designated as safety issue: No ]
| 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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00691288
| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada | |
| 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
No publications provided
| 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 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
omega-3 fatty acid hypertriglyceridemia HIV pediatric HAART |
Additional relevant MeSH terms:
|
Hypertriglyceridemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on March 03, 2015