Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients

Effect of Omega 3 Fatty Acids on Oxidative Stress in Seropositive HIV Patients

Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in the prevention of complications in seropositive for HIV patients. However, they develop some manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing cardiovascular risk.

Clinical trials in general population and in patients on hemodialysis have demonstrated a significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially triglycerides. Also in general populations it has been described a benefit effect of omega 3 acids on oxidative stress.

Objective: to know the effect of omega 3 acids on different markers of oxidative stress in seropositive HIV patients.

Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid peroxidation products) will be evaluated.

Sample size was calculated according to different variables. We selected the biggest one calculated for a difference in nitric oxide of 25% after treatment between groups and a standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of 31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost, a sample size of 35 per group was considered.

Study Overview

• Status: Completed
• Conditions: HIV/AIDS
• Intervention / Treatment: Drug: omega 3 fatty acids; Other: placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Mexico
  • Guanajuato
    • Leon, Guanajuato, Mexico, 37320
      • Instituto Mexicano del Seguro Social

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Seropositive HIV patients from 20 to 55 years old
• On clinical score A1, A2, B1 or B2
• Patients who received highly active antiretroviral therapy for at least 3 months.

Exclusion Criteria:

• Patients diagnosed with diabetes mellitus
• Patients diagnosed with hypertension
• Patients using hypolipidemic agents or diagnosed with dyslipidemia before receiving HAART therapy.
• Patients using protease inhibitors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omega 3 fatty acids; omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.	Drug: omega 3 fatty acids; omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.; Other Names: Zonelabs, Marblehead MA
Placebo Comparator: Placebo; Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)	Other: placebo; olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.; Other Names: olive oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients	The difference of this value at 6 months in relation to baseline value

Secondary Outcome Measures

Outcome Measure	Time Frame
Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients	The difference of this value at 6 months in relation to baseline value
Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients	The difference of this value at 6 months in relation to baseline value
Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients	The difference of this value at 6 months in relation to baseline value
Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients	The difference of this value at 6 months in relation to baseline value
Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients	The difference of this value at 6 months in relation to baseline value
Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients	The difference of this value at 6 months in relation to baseline value
Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients	The difference of this value at 6 months in relation to baseline value

Collaborators and Investigators

• Sponsor: Coordinación de Investigación en Salud, Mexico
• Collaborators: Instituto Mexicano del Seguro Social
• Investigators: Principal Investigator: Norma Amador, PhD, Instituto Mexicano del Seguro Social

Publications and helpful links

General Publications

• Amador-Licona N, Diaz-Murillo TA, Gabriel-Ortiz G, Pacheco-Moises FP, Pereyra-Nobara TA, Guizar-Mendoza JM, Barbosa-Sabanero G, Orozco-Avina G, Moreno-Martinez SC, Luna-Montalban R, Vazquez-Valls E. Omega 3 Fatty Acids Supplementation and Oxidative Stress in HIV-Seropositive Patients. A Clinical Trial. PLoS One. 2016 Mar 25;11(3):e0151637. doi: 10.1371/journal.pone.0151637. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 18, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Oxidative stress; Omega 3 fatty acids; Seropositive HIV
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R-2011-785-058