The Impact of Omega Three Fatty Acids on Vascular Function in HIV (HOST)
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ClinicalTrials.gov Identifier: NCT01041521 |
Recruitment Status
:
Completed
First Posted
: December 31, 2009
Last Update Posted
: December 15, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | December 30, 2009 | |||
First Posted Date ICMJE | December 31, 2009 | |||
Last Update Posted Date | December 15, 2016 | |||
Study Start Date ICMJE | January 2010 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
triglyceride level [ Time Frame: 24 months ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01041521 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
vascular function [ Time Frame: 6 months and 24 months ] | |||
Original Secondary Outcome Measures ICMJE |
vascular function [ Time Frame: 6 months ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Impact of Omega Three Fatty Acids on Vascular Function in HIV | |||
Official Title ICMJE | The Impact of Omega Three Fatty Acids on Vascular Function in HIV | |||
Brief Summary | The study seeks to determine if the use of omega three fatty acids in individuals infected with HIV and with high triglycerides leads to improved triglyceride levels, better blood vessel function and decrease in the amount of obstruction in blood vessels. | |||
Detailed Description | 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:
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Lovaza
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
Other Names:
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
129 | |||
Original Estimated Enrollment ICMJE |
150 | |||
Actual Study Completion Date | August 2015 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01041521 | |||
Other Study ID Numbers ICMJE | LVZ112667 1R01HL096585-01A1 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Christine A. Wanke, Tufts University | |||
Study Sponsor ICMJE | Christine A. Wanke | |||
Collaborators ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | |||
Investigators ICMJE |
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PRS Account | Tufts University | |||
Verification Date | December 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |