HIV/AIDS Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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