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

• Sponsor: Coordinación de Investigación en Salud, Mexico (Other)
• Overall Status: Completed
• CT.gov ID: NCT02041520
• Collaborator: Instituto Mexicano del Seguro Social (Other)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 28.9
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS	Drug: omega 3 fatty acids; Other: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: Effect of Omega 3 Fatty Acids on Oxidative Stress in Seropositive HIV Patients
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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)	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 Names: olive oil

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

6. 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]

7. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Instituto Mexicano del Seguro Social	Leon	Guanajuato	Mexico	37320

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norma Amador Licona, PhD, Coordinación de Investigación en Salud, Mexico
• ClinicalTrials.gov Identifier: NCT02041520
• Other Study ID Numbers: R-2011-785-058
• First Posted: Jan 22, 2014
• Last Update Posted: Aug 18, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Norma Amador Licona, PhD, Coordinación de Investigación en Salud, Mexico: Seropositive HIV; Omega 3 fatty acids; Oxidative stress
• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections

Study Results

Participant Flow

Arm/Group Title	Omega 3 Fatty Acids	Placebo
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	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.
Period Title: Overall Study
STARTED	35	35
COMPLETED	29	28
NOT COMPLETED	6	7

Baseline Characteristics

Arm/Group Title	Omega 3 Fatty Acids	Placebo	Total
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	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.	Total of all reporting groups
Overall Participants	35	35	70
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.9 (9.5)	39.9 (8.0)	39.9 (8.7)
Sex: Female, Male (Count of Participants)
Female	7 20%	12 34.3%	19 27.1%
Male	28 80%	23 65.7%	51 72.9%
Region of Enrollment (participants) [Number]
Mexico	35 100%	35 100%	70 100%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.4 (4.3)	26.5 (4.7)	25.9 (4.5)
Systolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	111.7 (11.3)	113.4 (13.2)	112.5 (12.3)
Diastolic blood pressure (mmHg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHg]	76.2 (8.1)	73.0 (10.6)	74.6 (9.5)
Glucose (mg/dL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dL]	90.3 (7.0)	91.5 (11.1)	90.9 (9.2)
Total cholesterol (mg/dL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/dL]	184	197	194.5
Triglycerides (mg/dL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/dL]	190	142	173
HDL cholesterol (mg/dL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/dL]	45	46	46
LDL cholesterol (mg/dL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/dL]	102	109.7	107
VLDL cholesterol (mg/dL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [mg/dL]	37	29	33
Time in HAART (months) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [months]	36	48	45.5
Alanine aminotransferase (UI/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [UI/L]	36	35.5	36
Aspartate aminotransferase (UI/L) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [UI/L]	31	28	30
Lipoperoxides (nM/mg protein) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [nM/mg protein]	1.94	2.0	2.0
Total-glutathione (μM) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [μM]	6.5	4.0	5.2
Oxidized-glutathione (μM) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [μM]	0.3	0.1	0.2
Reduced-glutathione (μM) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [μM]	4.4	2.5	3.4
Nitric oxide catabolites (μM/ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [μM/ml]	36.8 (14.2)	39.0 (13.2)	37.9 (13.6)
CD4 (cel/µL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [cel/µL]	473	595	488
CD8 (cel/µL) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [cel/µL]	985	1117	1017

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega 3 Fatty Acids	Placebo
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	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.
Measure Participants	29	28
Mean (95% Confidence Interval) [nM/mg protein]	-1.18	-0.9

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega 3 Fatty Acids	Placebo
Arm/Group Description	Patients who received omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and 2 in the night...	Patiemts who received placebo for 6 months
Measure Participants	29	28
Mean (95% Confidence Interval) [µM]	32.9	40.5

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega 3 Fatty Acids	Placebo
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	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.
Measure Participants	29	28
Mean (Standard Deviation) [µM/ml]	-21.1 (14.6)	-22.6 (14.6)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega 3 Fatty Acids	Placebo
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	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.
Measure Participants	29	28
Mean (95% Confidence Interval) [copies/ml]	-396	90

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega 3 Fatty Acids	Placebo
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	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.
Measure Participants	29	28
Mean (95% Confidence Interval) [µM]	1.1	15.0

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega 3 Fatty Acids	Placebo
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	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.
Measure Participants	29	28
Mean (95% Confidence Interval) [µM]	38.1	27.9

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega 3 Fatty Acids	Placebo
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	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.
Measure Participants	29	28
Mean (95% Confidence Interval) [UI/L]	4.0	5.0

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omega 3 Fatty Acids	Placebo
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.	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.
Measure Participants	29	28
Mean (95% Confidence Interval) [UI/L]	1.0	3.0

Adverse Events

Arm/Group Title	Omega 3 Fatty Acids		Placebo
Arm/Group 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. omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.		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.
All Cause Mortality
	Omega 3 Fatty Acids		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Omega 3 Fatty Acids		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Omega 3 Fatty Acids		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/35 (5.7%)		1/35 (2.9%)
Gastrointestinal disorders
diarrhea	1/35 (2.9%)	1	0/35 (0%)	0
biliar colic in patiet with cholelithiasis	0/35 (0%)	0	1/35 (2.9%)	1
Nervous system disorders
dizzines	1/35 (2.9%)	1	0/35 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.