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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition HIV/AIDS
Interventions Drug: omega 3 fatty acids
Other: placebo
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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 [1] 35 [2]
Completed 29 28
Not Completed 6 7
Reason Not Completed
Adverse Event             2             1
Withdrawal by Subject             3             4
Protocol Violation             1             0
Lost to Follow-up             0             1
Hypothiroidism identified during follow-             0             1
[1]
35 patients randomly assigned to omega 3 fatty acids
[2]
35 patients randomly assigned to placebo
Arm/Group Title Omega 3 Fatty Acids Placebo Total
Hide 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 Number of Baseline Participants 35 35 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants 35 participants 70 participants
39.9  (9.5) 39.9  (8.0) 39.9  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 35 participants 70 participants
Female
7
  20.0%
12
  34.3%
19
  27.1%
Male
28
  80.0%
23
  65.7%
51
  72.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mexico Number Analyzed 35 participants 35 participants 70 participants
35 35 70
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 35 participants 35 participants 70 participants
25.4  (4.3) 26.5  (4.7) 25.9  (4.5)
Systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 35 participants 35 participants 70 participants
111.7  (11.3) 113.4  (13.2) 112.5  (12.3)
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 35 participants 35 participants 70 participants
76.2  (8.1) 73.0  (10.6) 74.6  (9.5)
Glucose  
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 35 participants 35 participants 70 participants
90.3  (7.0) 91.5  (11.1) 90.9  (9.2)
Total cholesterol  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 35 participants 35 participants 70 participants
184
(162 to 222)
197
(171 to 215)
194.5
(165 to 219)
Triglycerides  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 35 participants 35 participants 70 participants
190
(131 to 228)
142
(119 to 206)
173
(126 to 214)
HDL cholesterol  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 35 participants 35 participants 70 participants
45
(38 to 52)
46
(38 to 52)
46
(38 to 52)
LDL cholesterol  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 35 participants 35 participants 70 participants
102
(82 to 131)
109.7
(99.9 to 122.5)
107
(88 to 123)
VLDL cholesterol  
Median (Inter-Quartile Range)
Unit of measure:  mg/dL
Number Analyzed 35 participants 35 participants 70 participants
37
(27 to 44)
29
(25 to 45)
33
(25.9 to 44.5)
Time in HAART  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 35 participants 35 participants 70 participants
36
(27 to 82)
48
(25 to 100)
45.5
(27 to 84)
Alanine aminotransferase  
Median (Inter-Quartile Range)
Unit of measure:  UI/L
Number Analyzed 35 participants 35 participants 70 participants
36
(28 to 46)
35.5
(28 to 48)
36
(28 to 46)
Aspartate aminotransferase  
Median (Inter-Quartile Range)
Unit of measure:  UI/L
Number Analyzed 35 participants 35 participants 70 participants
31
(24 to 36)
28
(21 to 37)
30
(22 to 36)
Lipoperoxides  
Median (Inter-Quartile Range)
Unit of measure:  nM/mg protein
Number Analyzed 35 participants 35 participants 70 participants
1.94
(1.6 to 3.1)
2.0
(1.6 to 2.8)
2.0
(1.6 to 2.8)
Total-glutathione  
Median (Inter-Quartile Range)
Unit of measure:  μM
Number Analyzed 35 participants 35 participants 70 participants
6.5
(2.6 to 30.6)
4.0
(0 to 26.4)
5.2
(1.8 to 28.8)
Oxidized-glutathione  
Median (Inter-Quartile Range)
Unit of measure:  μM
Number Analyzed 35 participants 35 participants 70 participants
0.3
(0 to 11.9)
0.1
(0 to 2.2)
0.2
(0 to 2.6)
Reduced-glutathione  
Median (Inter-Quartile Range)
Unit of measure:  μM
Number Analyzed 35 participants 35 participants 70 participants
4.4
(0 to 28.8)
2.5
(0 to 23.1)
3.4
(0 to 26.8)
Nitric oxide catabolites  
Mean (Standard Deviation)
Unit of measure:  μM/ml
Number Analyzed 35 participants 35 participants 70 participants
36.8  (14.2) 39.0  (13.2) 37.9  (13.6)
CD4  
Median (Inter-Quartile Range)
Unit of measure:  cel/µL
Number Analyzed 35 participants 35 participants 70 participants
473
(398 to 555)
595
(421 to 765)
488
(407 to 729)
CD8  
Median (Inter-Quartile Range)
Unit of measure:  cel/µL
Number Analyzed 35 participants 35 participants 70 participants
985
(652 to 1082)
1117
(742 to 1553)
1017
(708 to 1553)
1.Primary Outcome
Title Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Hide Description [Not Specified]
Time Frame The difference of this value at 6 months in relation to baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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.

Overall Number of Participants Analyzed 29 28
Mean (95% Confidence Interval)
Unit of Measure: nM/mg protein
-1.18
(-1.94 to -0.23)
-0.9
(-1.2 to -0.12)
2.Secondary Outcome
Title Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Hide Description [Not Specified]
Time Frame The difference of this value at 6 months in relation to baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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
Overall Number of Participants Analyzed 29 28
Mean (95% Confidence Interval)
Unit of Measure: µM
32.9
(18.9 to 72.2)
40.5
(26.4 to 65.8)
3.Secondary Outcome
Title Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Hide Description [Not Specified]
Time Frame The difference of this value at 6 months in relation to baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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.

Overall Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description [Not Specified]
Time Frame The difference of this value at 6 months in relation to baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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.

Overall Number of Participants Analyzed 29 28
Mean (95% Confidence Interval)
Unit of Measure: copies/ml
-396
(-1170 to -377)
90
(-258 to 440)
5.Secondary Outcome
Title Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Hide Description [Not Specified]
Time Frame The difference of this value at 6 months in relation to baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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.

Overall Number of Participants Analyzed 29 28
Mean (95% Confidence Interval)
Unit of Measure: µM
1.1
(-2.0 to 14.8)
15.0
(7.6 to 19.1)
6.Secondary Outcome
Title Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Hide Description [Not Specified]
Time Frame The difference of this value at 6 months in relation to baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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.

Overall Number of Participants Analyzed 29 28
Mean (95% Confidence Interval)
Unit of Measure: µM
38.1
(13.6 to 52.0)
27.9
(13.5 to 56.9)
7.Secondary Outcome
Title Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Hide Description [Not Specified]
Time Frame The difference of this value at 6 months in relation to baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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.

Overall Number of Participants Analyzed 29 28
Mean (95% Confidence Interval)
Unit of Measure: UI/L
4.0
(-4.0 to 14.0)
5.0
(-4.2 to 17.1)
8.Secondary Outcome
Title Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
Hide Description [Not Specified]
Time Frame The difference of this value at 6 months in relation to baseline value
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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.

Overall Number of Participants Analyzed 29 28
Mean (95% Confidence Interval)
Unit of Measure: UI/L
1.0
(-3.0 to 3.0)
3.0
(-2.0 to 5.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Omega 3 Fatty Acids Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Omega 3 Fatty Acids Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/35 (0.00%)      0/35 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Omega 3 Fatty Acids Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/35 (5.71%)      1/35 (2.86%)    
Gastrointestinal disorders     
diarrhea  1/35 (2.86%)  1 0/35 (0.00%)  0
biliar colic in patiet with cholelithiasis  0/35 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders     
dizzines  1/35 (2.86%)  1 0/35 (0.00%)  0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Norma Amador
Organization: Instituto Mexicano del Seguro Social, UMAE HE No. 1 Bajio
Phone: +524777174800 ext 31315
EMail: norma.amador@imss.gob.mx
Layout table for additonal information
Responsible Party: Norma Amador Licona, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT02041520    
Other Study ID Numbers: R-2011-785-058
First Submitted: January 17, 2014
First Posted: January 22, 2014
Results First Submitted: February 6, 2015
Results First Posted: February 23, 2015
Last Update Posted: August 18, 2015