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

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ClinicalTrials.gov Identifier: NCT02041520
Recruitment Status : Completed
First Posted : January 22, 2014
Results First Posted : February 23, 2015
Last Update Posted : August 18, 2015
Sponsor:
Collaborator:
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
Norma Amador Licona, Coordinación de Investigación en Salud, Mexico

Tracking Information
First Submitted Date  ICMJE January 17, 2014
First Posted Date  ICMJE January 22, 2014
Results First Submitted Date  ICMJE February 6, 2015
Results First Posted Date  ICMJE February 23, 2015
Last Update Posted Date August 18, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients [ Time Frame: The difference of this value at 6 months in relation to baseline value ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2014)
Change on malondialdehyde, nitric oxide and glutathion levels after treatment with omega 3 acids for 6 months compared with placebo [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2015)
  • Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: The difference of this value at 6 months in relation to baseline value ]
  • Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients [ Time Frame: The difference of this value at 6 months in relation to baseline value ]
  • Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients [ Time Frame: The difference of this value at 6 months in relation to baseline value ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients
Official Title  ICMJE Effect of Omega 3 Fatty Acids on Oxidative Stress in Seropositive HIV Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE HIV/AIDS
Intervention  ICMJE
  • 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
  • Other: 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.
    Other Name: olive oil
Study Arms  ICMJE
  • 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.
    Intervention: Drug: omega 3 fatty acids
  • 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)
    Intervention: Other: placebo
Publications * Amador-Licona N, Díaz-Murillo TA, Gabriel-Ortiz G, Pacheco-Moises FP, Pereyra-Nobara TA, Guízar-Mendoza JM, Barbosa-Sabanero G, Orozco-Aviña G, Moreno-Martínez SC, Luna-Montalbán R, Vázquez-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2014)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02041520
Other Study ID Numbers  ICMJE R-2011-785-058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norma Amador Licona, Coordinación de Investigación en Salud, Mexico
Study Sponsor  ICMJE Coordinación de Investigación en Salud, Mexico
Collaborators  ICMJE Instituto Mexicano del Seguro Social
Investigators  ICMJE
Principal Investigator: Norma Amador, PhD Instituto Mexicano del Seguro Social
PRS Account Coordinación de Investigación en Salud, Mexico
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP