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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041520
• Other study ID #: R-2011-785-058
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2014
• Last updated: July 28, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Protection Against Health Risks
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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.

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social	Leon	Guanajuato

Sponsors (2)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes