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

NCT ID: NCT02041520

Last Updated: 2015-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Omega 3 fatty acids

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.

Group Type: EXPERIMENTAL

omega 3 fatty acids

Intervention Type: DRUG

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

Placebo

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)

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: 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.

Interventions

omega 3 fatty acids

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

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Zonelabs, Marblehead MA; olive oil

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role: collaborator

Coordinación de Investigación en Salud, Mexico

OTHER_GOV

Sponsor Role: lead

Responsible Party

Norma Amador Licona

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norma Amador, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto Mexicano del Seguro Social

Locations

Instituto Mexicano del Seguro Social

León, Guanajuato, Mexico

Countries

Mexico

References

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.

Reference Type: DERIVED

PMID: 27015634 (View on PubMed)

Other Identifiers

R-2011-785-058

Identifier Type: -

Identifier Source: org_study_id