Fish Oil for HIV-Related Inflamm-aging and Immune Senescence

NCT02102724 | Completed Results DMC

• 1 other identifier: 5P20MD006886
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection

Keywords

African Americans; Older Adults

Outcome Measures

Primary Outcomes (1)

• Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation

  Markers of immune senescence will include change in the expression of the senescence markers CD28 and CD57 on the surface of peripheral CD4+ and CD8+ T lymphocytes. We will measure the percentage of CD4+ and CD8+ T lymphocytes that are CD28-/CD57- or CD28-/CD57+. We will subtract the percentage obtained at Week 12 from the baseline percentage to calculate the change scores.

  End of 12-Week Supplementation Period

Study Arms (2)

Fish Oil

EXPERIMENTAL

Participants will receive fish oil gelcaps that contain 1.6 grams of omega-3 fatty acids (800 mg of EPA, 600 mg DHA, 200 mg other omega-3 fatty acids) for 12 weeks.

Dietary Supplement: Fish oil that contains omega-3 fatty acids

Placebo

PLACEBO COMPARATOR

Participants will receive 1 gram of oleic sunflower oil for 12 weeks.

Dietary Supplement: Placebo

Interventions

Fish oil that contains omega-3 fatty acids DIETARY_SUPPLEMENT

Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids

Also known as: Carlson Brand fish oil

Fish Oil

Placebo DIETARY_SUPPLEMENT

Gelcaps that contain 1 gram of oleic sunflower oil

Placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \< 75 copies/ml for at least 12 months
• elevated plasma concentration of hsCRP (\> 2.0 mg/L).

You may not qualify if:

• 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 \< 150,000/mm3), bleeding episodes (e.g., gum bleeding, nosebleeds), or a metabolic condition (e.g., diabetes mellitus, thyroid disease)
• body mass index of \> 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Small sample size; only single dose tested; duration may be too short to detect effects

Results Point of Contact

• Title: Barbara Swanson
• Organization: Rush University College of Nursing

BARBARA_A_SWANSON@RUSH.EDU

3129428977

Study Officials

• Barbara A. Swanson, PhD, RN

  Rush University College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: All gelcaps were overencapsulated to mask their contents
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants were randomized to one of two arms: Intervention arm = fish oil Control arm = placebo.

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 3, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 26, 2019
• Results First Posted: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)