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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:
Collaborators:
Canadian Foundation for AIDS Research (CANFAR)
PSI Foundation inc
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

May 27, 2008
June 10, 2014
June 2008
October 2011   (final data collection date for primary outcome measure)
Percentage change in triglyceride levels [ Time Frame: 4 and 12 weeks after beginning treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00691288 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children
Effect of Omega-3 Fatty Acid Supplementation on Hypertriglyceridemia in HIV-infected Children Taking Highly Active Antiretroviral Therapy (HAART): a Randomized Cross-over Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertriglyceridemia
  • 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
  • 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
  • Experimental: 1
    Intervention: Drug: Omega Pure followed by placebo
  • Experimental: 2
    Intervention: Drug: Placebo followed by Omega Pure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
December 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00691288
1000011295
No
Ari Bitnun, The Hospital for Sick Children
The Hospital for Sick Children
  • Canadian Foundation for AIDS Research (CANFAR)
  • PSI Foundation inc
  • Ocean Nutrition
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
The Hospital for Sick Children
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP