Trial Outcomes & Findings for Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients (NCT NCT02041520)
NCT ID: NCT02041520
Last Updated: 2015-08-18
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
70 participants
Primary outcome timeframe
The difference of this value at 6 months in relation to baseline value
Results posted on
2015-08-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Hypothiroidism identified during follow-
|
0
|
1
|
Baseline Characteristics
Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients
Baseline characteristics by cohort
| Measure |
Omega 3 Fatty Acids
n=35 Participants
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
n=35 Participants
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
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 9.5 • n=93 Participants
|
39.9 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
39.9 years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Region of Enrollment
Mexico
|
35 participants
n=93 Participants
|
35 participants
n=4 Participants
|
70 participants
n=27 Participants
|
|
Body mass index
|
25.4 kg/m^2
STANDARD_DEVIATION 4.3 • n=93 Participants
|
26.5 kg/m^2
STANDARD_DEVIATION 4.7 • n=4 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 4.5 • n=27 Participants
|
|
Systolic blood pressure
|
111.7 mmHg
STANDARD_DEVIATION 11.3 • n=93 Participants
|
113.4 mmHg
STANDARD_DEVIATION 13.2 • n=4 Participants
|
112.5 mmHg
STANDARD_DEVIATION 12.3 • n=27 Participants
|
|
Diastolic blood pressure
|
76.2 mmHg
STANDARD_DEVIATION 8.1 • n=93 Participants
|
73.0 mmHg
STANDARD_DEVIATION 10.6 • n=4 Participants
|
74.6 mmHg
STANDARD_DEVIATION 9.5 • n=27 Participants
|
|
Glucose
|
90.3 mg/dL
STANDARD_DEVIATION 7.0 • n=93 Participants
|
91.5 mg/dL
STANDARD_DEVIATION 11.1 • n=4 Participants
|
90.9 mg/dL
STANDARD_DEVIATION 9.2 • n=27 Participants
|
|
Total cholesterol
|
184 mg/dL
n=93 Participants
|
197 mg/dL
n=4 Participants
|
194.5 mg/dL
n=27 Participants
|
|
Triglycerides
|
190 mg/dL
n=93 Participants
|
142 mg/dL
n=4 Participants
|
173 mg/dL
n=27 Participants
|
|
HDL cholesterol
|
45 mg/dL
n=93 Participants
|
46 mg/dL
n=4 Participants
|
46 mg/dL
n=27 Participants
|
|
LDL cholesterol
|
102 mg/dL
n=93 Participants
|
109.7 mg/dL
n=4 Participants
|
107 mg/dL
n=27 Participants
|
|
VLDL cholesterol
|
37 mg/dL
n=93 Participants
|
29 mg/dL
n=4 Participants
|
33 mg/dL
n=27 Participants
|
|
Time in HAART
|
36 months
n=93 Participants
|
48 months
n=4 Participants
|
45.5 months
n=27 Participants
|
|
Alanine aminotransferase
|
36 UI/L
n=93 Participants
|
35.5 UI/L
n=4 Participants
|
36 UI/L
n=27 Participants
|
|
Aspartate aminotransferase
|
31 UI/L
n=93 Participants
|
28 UI/L
n=4 Participants
|
30 UI/L
n=27 Participants
|
|
Lipoperoxides
|
1.94 nM/mg protein
n=93 Participants
|
2.0 nM/mg protein
n=4 Participants
|
2.0 nM/mg protein
n=27 Participants
|
|
Total-glutathione
|
6.5 μM
n=93 Participants
|
4.0 μM
n=4 Participants
|
5.2 μM
n=27 Participants
|
|
Oxidized-glutathione
|
0.3 μM
n=93 Participants
|
0.1 μM
n=4 Participants
|
0.2 μM
n=27 Participants
|
|
Reduced-glutathione
|
4.4 μM
n=93 Participants
|
2.5 μM
n=4 Participants
|
3.4 μM
n=27 Participants
|
|
Nitric oxide catabolites
|
36.8 μM/ml
STANDARD_DEVIATION 14.2 • n=93 Participants
|
39.0 μM/ml
STANDARD_DEVIATION 13.2 • n=4 Participants
|
37.9 μM/ml
STANDARD_DEVIATION 13.6 • n=27 Participants
|
|
CD4
|
473 cel/µL
n=93 Participants
|
595 cel/µL
n=4 Participants
|
488 cel/µL
n=27 Participants
|
|
CD8
|
985 cel/µL
n=93 Participants
|
1117 cel/µL
n=4 Participants
|
1017 cel/µL
n=27 Participants
|
PRIMARY outcome
Timeframe: The difference of this value at 6 months in relation to baseline valueOutcome measures
| Measure |
Omega 3 Fatty Acids
n=29 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Change on Malondialdehyde After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
|
-1.18 nM/mg protein
Interval -1.94 to -0.23
|
-0.9 nM/mg protein
Interval -1.2 to -0.12
|
SECONDARY outcome
Timeframe: The difference of this value at 6 months in relation to baseline valueOutcome measures
| Measure |
Omega 3 Fatty Acids
n=29 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Change on Total Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
|
32.9 µM
Interval 18.9 to 72.2
|
40.5 µM
Interval 26.4 to 65.8
|
SECONDARY outcome
Timeframe: The difference of this value at 6 months in relation to baseline valueOutcome measures
| Measure |
Omega 3 Fatty Acids
n=29 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Change on Nitric Oxide After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
|
-21.1 µM/ml
Standard Deviation 14.6
|
-22.6 µM/ml
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: The difference of this value at 6 months in relation to baseline valueOutcome measures
| Measure |
Omega 3 Fatty Acids
n=29 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Change on Viral Load After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
|
-396 copies/ml
Interval -1170.0 to -377.0
|
90 copies/ml
Interval -258.0 to 440.0
|
SECONDARY outcome
Timeframe: The difference of this value at 6 months in relation to baseline valueOutcome measures
| Measure |
Omega 3 Fatty Acids
n=29 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Change on Oxidized- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
|
1.1 µM
Interval -2.0 to 14.8
|
15.0 µM
Interval 7.6 to 19.1
|
SECONDARY outcome
Timeframe: The difference of this value at 6 months in relation to baseline valueOutcome measures
| Measure |
Omega 3 Fatty Acids
n=29 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Change on Reduced- Glutathion After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
|
38.1 µM
Interval 13.6 to 52.0
|
27.9 µM
Interval 13.5 to 56.9
|
SECONDARY outcome
Timeframe: The difference of this value at 6 months in relation to baseline valueOutcome measures
| Measure |
Omega 3 Fatty Acids
n=29 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Change on Alanine Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
|
4.0 UI/L
Interval -4.0 to 14.0
|
5.0 UI/L
Interval -4.2 to 17.1
|
SECONDARY outcome
Timeframe: The difference of this value at 6 months in relation to baseline valueOutcome measures
| Measure |
Omega 3 Fatty Acids
n=29 Participants
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
n=28 Participants
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.
|
|---|---|---|
|
Change on Aspartate Aminotransferase After Treatment With Omega 3 Acids for 6 Months Compared With Placebo in HIV Seropositive Patients
|
1.0 UI/L
Interval -3.0 to 3.0
|
3.0 UI/L
Interval -2.0 to 5.0
|
Adverse Events
Omega 3 Fatty Acids
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Omega 3 Fatty Acids
n=35 participants at risk
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
n=35 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
2.9%
1/35 • Number of events 1
|
0.00%
0/35
|
|
Nervous system disorders
dizzines
|
2.9%
1/35 • Number of events 1
|
0.00%
0/35
|
|
Gastrointestinal disorders
biliar colic in patiet with cholelithiasis
|
0.00%
0/35
|
2.9%
1/35 • Number of events 1
|
Additional Information
Dr. Norma Amador
Instituto Mexicano del Seguro Social, UMAE HE No. 1 Bajio
Phone: +524777174800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place