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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02041520

Enrollment

Registered

2014-01-22

Start date

2013-01-31

Completion date

2015-06-30

Last updated

2015-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Keywords

Seropositive HIV, Omega 3 fatty acids, Oxidative stress

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.

Interventions

DRUGomega 3 fatty acids

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

OTHERplacebo

olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 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 Alanine Aminotransferase 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 Aspartate Aminotransferase 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

Countries

Mexico

Participant flow

Participants by arm

Arm	Count
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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	35
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) omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	35
Total	70

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	2	1
Overall Study	Hypothiroidism identified during follow-	0	1
Overall Study	Lost to Follow-up	0	1
Overall Study	Protocol Violation	1	0
Overall Study	Withdrawal by Subject	3	4

Baseline characteristics

Characteristic	Omega 3 Fatty Acids	Placebo	Total
Age, Continuous	39.9 years STANDARD_DEVIATION 9.5	39.9 years STANDARD_DEVIATION 8	39.9 years STANDARD_DEVIATION 8.7
Alanine aminotransferase	36 UI/L	35.5 UI/L	36 UI/L
Aspartate aminotransferase	31 UI/L	28 UI/L	30 UI/L
Body mass index	25.4 kg/m^2 STANDARD_DEVIATION 4.3	26.5 kg/m^2 STANDARD_DEVIATION 4.7	25.9 kg/m^2 STANDARD_DEVIATION 4.5
CD4	473 cel/µL	595 cel/µL	488 cel/µL
CD8	985 cel/µL	1117 cel/µL	1017 cel/µL
Diastolic blood pressure	76.2 mmHg STANDARD_DEVIATION 8.1	73.0 mmHg STANDARD_DEVIATION 10.6	74.6 mmHg STANDARD_DEVIATION 9.5
Glucose	90.3 mg/dL STANDARD_DEVIATION 7	91.5 mg/dL STANDARD_DEVIATION 11.1	90.9 mg/dL STANDARD_DEVIATION 9.2
HDL cholesterol	45 mg/dL	46 mg/dL	46 mg/dL
LDL cholesterol	102 mg/dL	109.7 mg/dL	107 mg/dL
Lipoperoxides	1.94 nM/mg protein	2.0 nM/mg protein	2.0 nM/mg protein
Nitric oxide catabolites	36.8 μM/ml STANDARD_DEVIATION 14.2	39.0 μM/ml STANDARD_DEVIATION 13.2	37.9 μM/ml STANDARD_DEVIATION 13.6
Oxidized-glutathione	0.3 μM	0.1 μM	0.2 μM
Reduced-glutathione	4.4 μM	2.5 μM	3.4 μM
Region of Enrollment Mexico	35 participants	35 participants	70 participants
Sex: Female, Male Female	7 Participants	12 Participants	19 Participants
Sex: Female, Male Male	28 Participants	23 Participants	51 Participants
Systolic blood pressure	111.7 mmHg STANDARD_DEVIATION 11.3	113.4 mmHg STANDARD_DEVIATION 13.2	112.5 mmHg STANDARD_DEVIATION 12.3
Time in HAART	36 months	48 months	45.5 months
Total cholesterol	184 mg/dL	197 mg/dL	194.5 mg/dL
Total-glutathione	6.5 μM	4.0 μM	5.2 μM
Triglycerides	190 mg/dL	142 mg/dL	173 mg/dL
VLDL cholesterol	37 mg/dL	29 mg/dL	33 mg/dL

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	2 / 35	1 / 35
serious Total, serious adverse events	0 / 35	0 / 35