Overview

This trial is active, not recruiting.

Condition hiv/aids
Treatments omega 3 fatty acids, placebo
Phase phase 3
Sponsor Coordinación de Investigación en Salud, Mexico
Collaborator Instituto Mexicano del Seguro Social
Start date January 2013
End date May 2014
Trial size 70 participants
Trial identifier NCT02041520, R-2011-785-058

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
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.
omega 3 fatty acids Zonelabs, Marblehead MA
omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.
(Placebo Comparator)
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)
placebo olive oil
olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.

Primary Outcomes

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

Secondary Outcomes

Measure
Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: The difference of this value at 6 months in relation to baseline value

Eligibility Criteria

Male or female participants from 20 years up to 60 years old.

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

Additional Information

Official title Effect of Omega 3 Fatty Acids on Oxidative Stress in Seropositive HIV Patients
Principal investigator Norma Amador, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Coordinación de Investigación en Salud, Mexico.