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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02102724
Recruitment Status : Completed
First Posted : April 3, 2014
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition HIV Infection
Interventions Dietary Supplement: Fish oil that contains omega-3 fatty acids
Dietary Supplement: Placebo
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fish Oil Placebo
Hide Arm/Group Description

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.

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

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

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

Period Title: Overall Study
Started 18 19
Completed 16 18
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             1             0
surgery for brain aneurysm             1             1
Arm/Group Title Fish Oil Placebo Total
Hide Arm/Group Description

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.

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

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

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

Total of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 37 participants
55  (5.4) 53  (6.1) 54  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
9
  50.0%
9
  47.4%
18
  48.6%
Male
9
  50.0%
10
  52.6%
19
  51.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 19 participants 37 participants
18 19 37
1.Primary Outcome
Title Change in Markers of Immune Senescence Between Baseline Values and Values After 12 Weeks of Supplementation
Hide Description 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.
Time Frame End of 12-Week Supplementation Period
Hide Outcome Measure Data
Hide Analysis Population Description
Wilcoxon rank sum tests for intergroup change scores
Arm/Group Title Fish Oil Placebo
Hide Arm/Group Description:

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.

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

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

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

Overall Number of Participants Analyzed 18 19
Mean (95% Confidence Interval)
Unit of Measure: percentage of cells
Percent CD4+ cells CD28+/CD57-
1.87
(-2.8 to 6.5)
4.22
(-3.5 to 11.9)
Percent CD4+ cells CD28-/CD57-
-2.83
(-6.9 to 1.2)
-1.56
(-3.0 to -0.08)
Percent CD4+ cells CD28-/CD57+
0.69
(-1.2 to 2.5)
-2.41
(-9.6 to 4.8)
Percent CD8+ cells CD28+/CD57-
-1.58
(-10.8 to 7.7)
-4.63
(-19.6 to 10.4)
Percent CD8+ cells CD28-/CD57-
-3.6
(-7.7 to 0.5)
0.79
(-4.8 to 6.4)
Percent CD8+ cells CD28-/CD57+
-2.37
(-8.7 to 4.4)
1.96
(-6.2 to 10.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fish Oil, Placebo
Comments The null hypotheses were that there are no differences between the two groups' change scores for any study outcomes. The power analysis was based on a study of krill oil for reducing CRP levels in persons with arthritis (N = 90) that yielded an effect size (Cohen’s d) of 1.2. A sample size of 37 was determined to yield a power of 0.80 to detect an effect size of 1.0 with a two-tailed alpha of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Other Statistical Analysis The change scores of the two groups (week 12 minus baseline) were compared using Wilcoxon rank sum tests.
Time Frame Over the 12-week supplementation period
Adverse Event Reporting Description Adverse event data were collected at baseline, week four and week 12.
 
Arm/Group Title Fish Oil Placebo
Hide Arm/Group Description

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.

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

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

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

All-Cause Mortality
Fish Oil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/19 (0.00%)    
Hide Serious Adverse Events
Fish Oil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/18 (5.56%)      1/19 (5.26%)    
Blood and lymphatic system disorders     
lymphoma *  0/18 (0.00%)  0 1/19 (5.26%)  1
Nervous system disorders     
brain aneurysm *  1/18 (5.56%)  1 0/19 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Fish Oil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/18 (44.44%)      4/19 (21.05%)    
Gastrointestinal disorders     
GI disturbance *  8/18 (44.44%)  8 4/19 (21.05%)  4
*
Indicates events were collected by non-systematic assessment
Small sample size; only single dose tested; duration may be too short to detect effects
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Barbara Swanson
Organization: Rush University College of Nursing
Phone: 3129428977
EMail: BARBARA_A_SWANSON@RUSH.EDU
Layout table for additonal information
Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02102724    
Other Study ID Numbers: 5P20MD006886 ( U.S. NIH Grant/Contract )
First Submitted: March 31, 2014
First Posted: April 3, 2014
Results First Submitted: August 13, 2018
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019