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

Summary

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.

Conditions

• HIV/AIDS

Interventions

DRUG

omega 3 fatty acids

omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.

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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social

  collaborator OTHER_GOV

• Coordinación de Investigación en Salud, Mexico

  lead OTHER_GOV

Principal Investigators

• Norma Amador, PhD · Instituto Mexicano del Seguro Social

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2014-05-31

Completion

2015-06-30

Countries

• Mexico

Study Locations