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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Drug: omega 3 fatty acids
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omega 3 fatty acids<br>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. | Drug: omega 3 fatty acids<br>* omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.<br>* Other names: Zonelabs, Marblehead MA;|
| Placebo Comparator: Placebo<br>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) | Other: placebo<br>* olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.<br>* Other names: olive oil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Seropositive HIV, Omega 3 fatty acids, Oxidative stress