Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients
Primary Purpose
HIV/AIDS
Status
Completed
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
omega 3 fatty acids
placebo
Sponsored by
About this trial
This is an interventional supportive care trial for HIV/AIDS focused on measuring Seropositive HIV, Omega 3 fatty acids, Oxidative stress
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
Sites / Locations
- Instituto Mexicano del Seguro Social
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omega 3 fatty acids
Placebo
Arm 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.
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)
Outcomes
Primary Outcome Measures
Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Secondary Outcome Measures
Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Full Information
NCT ID
NCT02041520
First Posted
January 17, 2014
Last Updated
July 28, 2015
Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Instituto Mexicano del Seguro Social
1. Study Identification
Unique Protocol Identification Number
NCT02041520
Brief Title
Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients
Official Title
Effect of Omega 3 Fatty Acids on Oxidative Stress in Seropositive HIV Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Coordinación de Investigación en Salud, Mexico
Collaborators
Instituto Mexicano del Seguro Social
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
Seropositive HIV, Omega 3 fatty acids, Oxidative stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omega 3 fatty acids
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
omega 3 fatty acids
Other Intervention Name(s)
Zonelabs, Marblehead MA
Intervention Description
omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
olive oil
Intervention Description
olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norma Amador, PhD
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Mexicano del Seguro Social
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37320
Country
Mexico
12. IPD Sharing Statement
Citations:
PubMed Identifier
27015634
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients
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