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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Rush University Medical Center
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT02102724
First received: March 31, 2014
Last updated: April 2, 2014
Last verified: March 2014
  Purpose

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 African American older adults.


Condition Intervention Phase
HIV Infection
Dietary Supplement: Fish oil that contains omega-3 fatty acids
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Fish Oil for HIV-Related Inflamm-aging and Immune Senescence

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Markers of Immune Senescence [ Time Frame: End of 12-Week Supplementation Period ] [ Designated as safety issue: Yes ]
    Markers of immune senescence will include the expression of CD28 and CD57 on CD4+ and CD8+ T lymphocytes


Estimated Enrollment: 38
Study Start Date: April 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fish Oil
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
Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
Other Name: Carlson Brand fish oil
Placebo Comparator: Placebo
Participants will receive 1 gram of oleic sunflower oil for 12 weeks.
Dietary Supplement: Fish oil that contains omega-3 fatty acids
Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
Other Name: Carlson Brand fish oil

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • documented HIV infection
  • between 50 and 65 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 (> 3.0 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 < 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
  • lifestyle exclusion factors include use of illicit drugs and consumption of > 3 alcoholic drinks/day
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102724

Contacts
Contact: Barbara Swanson, PhD, RN 312-942-8977 barbara_a_swanson@rush.edu
Contact: Joyce Keithley, DNSc, RN 312-942-5820 joyce_k_keithley@rush.edu

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Principal Investigator: Barbara A. Swanson, PhD, RN Rush University College of Nursing
  More Information

No publications provided

Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02102724     History of Changes
Other Study ID Numbers: 5P20MD006886
Study First Received: March 31, 2014
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
African Americans
Older Adults

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 14, 2014