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

C

Coordinación de Investigación en Salud, Mexico

Status and phase

Completed
Phase 3

Conditions

HIV/AIDS

Treatments

Drug: omega 3 fatty acids
Other: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02041520
R-2011-785-058

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups, including a placebo group

Omega 3 fatty acids
Experimental group
Description:
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.
Treatment:
Drug: omega 3 fatty acids
Placebo
Placebo Comparator group
Description:
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)
Treatment:
Other: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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