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

Phase 3

Completed

• Conditions: HIV/AIDS
• Interventions: Other: placebo; Drug: omega 3 fatty acids

• Registration Number: NCT02041520
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-22
• Primary Completion: 2014-05
• Results First Submitted: 2015-02-06
• Results First Submitted QC: 2015-02-06
• Results First Posted: 2015-02-23
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-28
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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)
Omega 3 fatty acids	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Instituto Mexicano del Seguro Social; 🇲🇽 Leon, Guanajuato, Mexico