Clinical trial NCT02041520: Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients
Official title: Effect of Omega 3 Fatty Acids on Oxidative Stress in Seropositive HIV Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV/AIDS
Keywords: Seropositive HIV
Omega 3 fatty acids
Oxidative stress
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Mexicano del Seguro Social
First posted: 2014-01-22
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
timeFrame: 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
timeFrame: The difference of this value at 6 months in relation to baseline value
measure: Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
timeFrame: The difference of this value at 6 months in relation to baseline value
measure: Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
timeFrame: The difference of this value at 6 months in relation to baseline value
measure: Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
timeFrame: The difference of this value at 6 months in relation to baseline value
measure: Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
timeFrame: The difference of this value at 6 months in relation to baseline value
measure: Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
timeFrame: The difference of this value at 6 months in relation to baseline value
measure: Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
timeFrame: The difference of this value at 6 months in relation to baseline value
Other outcomes:
Locations:
city: Leon
country: Mexico
facility: Instituto Mexicano del Seguro Social
state: Guanajuato
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Norma Amador, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amador-Licona N, Diaz-Murillo TA, Gabriel-Ortiz G, Pacheco-Moises FP, Pereyra-Nobara TA, Guizar-Mendoza JM, Barbosa-Sabanero G, Orozco-Avina G, Moreno-Martinez SC, Luna-Montalban R, Vazquez-Valls E. Omega 3 Fatty Acids Supplementation and Oxidative Stress in HIV-Seropositive Patients. A Clinical Trial. PLoS One. 2016 Mar 25;11(3):e0151637. doi: 10.1371/journal.pone.0151637. eCollection 2016.