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

NCT02041520 | Completed Phase 3 Results

• 1 other identifier: R-2011-785-058
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Seropositive HIV; Omega 3 fatty acids; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Omega 3 fatty acids

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

omega 3 fatty acids DRUG

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

Also known as: Zonelabs, Marblehead MA

Omega 3 fatty acids

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.

Also known as: olive oil

Placebo

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead
• Instituto Mexicano del Seguro Social: collaborator

Study Sites (1)

Instituto Mexicano del Seguro Social

León, Guanajuato, 37320, Mexico

Location

Related Publications (1)

• 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.

  PMID: 27015634 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Fatty Acids, Omega-3; Olive Oil

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Fats, Unsaturated; Plant Oils; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Norma Amador
• Organization: Instituto Mexicano del Seguro Social, UMAE HE No. 1 Bajio

norma.amador@imss.gob.mx

+524777174800

Study Officials

• Norma Amador, PhD

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 17, 2014
• First Posted: January 22, 2014
• Study Start: January 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2015
• Last Updated: August 18, 2015
• Results First Posted: February 23, 2015

Record last verified: 2015-07

Locations

ME (1)