N/A
N=37
Fish Oil for HIV-Related Inflamm-aging and Immune Senescence
HIV Infection
Bottom Line
View on ClinicalTrials.gov: NCT02102724 ↗Enrolled (actual)
37
Serious AEs
5.4%
Results posted
Mar 2019
Primary outcome: Primary: Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation — 1.87; 4.22; -2.83; -1.56 percentage of cells — p=< 0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fish oil that contains omega-3 fatty acids (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation |
1.87; 4.22; -2.83; -1.56; 0.69; -2.41 | < 0.05 sig |
Summary
HIV infection is associated with premature aging of the immune system. It is believe that the persistent inflammation that accompanies HIV infection is a major contributor to premature immune aging. Fish oil has well-documented anti-inflammatory properties. In this randomized, clinical trial, we're testing whether a 12-week course of fish oil supplementation will reverse premature aging in HIV-infected older adults.
Eligibility Criteria
Inclusion Criteria
- documented HIV infection
- between 40 and 70 years of age
- clinically stable HIV disease as evidenced by a CD4+ T lymphocyte count of > 250 cells/mm3
- platelet count between 150, 000 and 400,000 cells/mm3 to reduce bleeding risks associated with omega 3-fatty acids
- treatment with a stable HAART regimen for at least six months prior to study entry
- plasma HIV RNA 2.0 mg/L).
Exclusion Criteria
- use within the past month of drugs (e.g., statins, steroids, hormones) and supplements (e.g., omega-3 fatty acids, glucosamine/chondroitin) that have anti-inflammatory effects (excluding non-regular use of aspirin or NSAIDS), or medications or supplements that affect bleeding (e.g., heparin, warfarin, clopidogrel, garlic, ginseng)
- allergy to fish or shellfish
- chronic inflammatory condition (e.g., asthma, rheumatoid arthritis), opportunistic infection or cancer, renal impairment (serum creatinine > 2.0 mg/dL), thrombocytopenia (platelet count 35, since obesity is associated with inflammation
- impaired liver function as evidenced by liver enzyme elevations > three times the upper limit of normal (AST or ALT > 150 IU/L)
- history of prostate cancer
- LDL cholesterol level > 120 mg/dL
- lifestyle exclusion factors include use of illicit drugs and consumption of > 3 alcoholic drinks/day
Data sourced from ClinicalTrials.gov (NCT02102724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.