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

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 3

Conditions: HIV/AIDS

Treatments: Drug: omega 3 fatty acids; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02041520

R-2011-785-058

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups, including a placebo group

Omega 3 fatty acids

Experimental group

Description:

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.

Treatment:

Drug: omega 3 fatty acids

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Other: placebo