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Completed

NCT Number: NCT02041520

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega 3 fatty acids

Drug

omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.

Other names: Zonelabs, Marblehead MA

Placebo

Other

olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.

Other names: olive oil

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Coordinación de Investigación en Salud, Mexico

Other Gov

Collaborators

  • Instituto Mexicano del Seguro Social

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 22, 2014
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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