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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Coordinación de Investigación en Salud, Mexico
Sponsor:
Collaborator:
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
Norma Amador Licona, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT02041520
First received: January 17, 2014
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
HIV/AIDS
Drug: omega 3 fatty acids
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Omega 3 Fatty Acids on Oxidative Stress in Seropositive HIV Patients

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Change on malondialdehyde after treatment with omega 3 acids for 6 months compared with placebo in HIV seropositive patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change on total glutathion after treatment with omega 3 acids for 6 months compared with placebo in HIV seropositive patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change on nitric oxide after treatment with omega 3 acids for 6 months compared with placebo in HIV seropositive patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change on viral load after treatment with omega 3 acids for 6 months compared with placebo in HIV seropositive patients [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: omega 3 fatty acids
omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.
Other Name: Zonelabs, Marblehead MA
Placebo Comparator: 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)
Drug: omega 3 fatty acids
omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.
Other Name: Zonelabs, Marblehead MA

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041520

Contacts
Contact: Norma Amador, PhD +524777174800 ext 31315 norma.amador@imss.gob.mx
Contact: Texar A Pereyra, MD +524777174800 ext 31742 texar.pereyra@imss.gob.mx

Locations
Mexico
Instituto Mexicano del Seguro Social Recruiting
Leon, Guanajuato, Mexico, 37320
Contact: Norma Amador, PhD    +52477174800 ext 31315    norma.amador@imss.gob.mx   
Contact: Texar A Amador, MD    +524777174800 ext 31742    texar.pereyra@imss.gob.mx   
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Norma Amador, PhD Instituto Mexicano del Seguro Social
  More Information

No publications provided

Responsible Party: Norma Amador Licona, PhD, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02041520     History of Changes
Other Study ID Numbers: R-2011-785-058
Study First Received: January 17, 2014
Last Updated: January 22, 2014
Health Authority: Mexico: Federal Commission for Protection Against Health Risks

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Seropositive HIV
Omega 3 fatty acids
Oxidative stress

ClinicalTrials.gov processed this record on July 29, 2014