The Impact of Omega Three Fatty Acids on Vascular Function in HIV (HOST)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Impact of Omega Three Fatty Acids on Vascular Function in HIV|
- triglyceride level [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- vascular function [ Time Frame: 6 months and 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Lovaza (omega three fatty acid)
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks.
Lovaza was previously known as Omacor (omega-3-acid ethyl esters) capsules
Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 24 months
No Intervention: sugar pill
Dietary Supplement: sugar pill
2 capsules given twice daily Arms: sugar pill
While omega-three fatty acids have been shown to be beneficial for TG and HDL-C levels in HIV uninfected individuals and in some small, short duration studies in HIV-infected individuals, there are no data that extend these observations to determine whether intake of omega-three fats over a more prolonged time period will also have a beneficial impact on functional outcomes such as vascular endothelial function and anatomic surrogate markers of CVD in HIV-infected patients.
We propose a randomized, double blind trial of purified omega-three fatty acids in HIV-infected individuals with elevated levels of triglycerides. While the impact of omega-three fatty acids on lipid profiles should be evident early (within 12 weeks); we propose to conduct this trial for a full 24 months to test our overall hypothesis that this intervention will not only improve triglyceride and HDL-C levels, improve HDL-subpopulations, plasma and membrane phospholipids and decrease inflammation, but will also improve brachial artery reactivity testing (BART) as a measure of vascular endothelial function at 24 weeks and 24 months and arterial stiffness measured by a pulse wave velocity test as a surrogate marker of CVD risk at 24 months when compared to controls.
The specific aims of this proposal include:
- To conduct a randomized, placebo controlled trial of omega-three fatty acids over 24 months in HIV-infected individuals with elevated levels of triglycerides (> 150 mg/dl).
- To demonstrate the impact of omega-three fatty acid intake on TG levels and on HDL-C levels, HDL subpopulations, composition of plasma and membrane phospholipids, and chronic inflammation as measured by CRP, sPLA2 and by levels of arachidonic acid.
- To demonstrate the impact of omega-three fatty acid intake on BART at 24 weeks and 24 months and on arterial stiffness at 24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041521
|United States, Massachusetts|
|Tufts University School of Medicine|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Christine A Wanke, MD||Tufts University|