Trial Outcomes & Findings for Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD) (NCT NCT04198805)
NCT ID: NCT04198805
Last Updated: 2023-05-25
Results Overview
A change in liver fat content relative to baseline between Vitamin E and DHA EE vs placebo. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
205 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2023-05-25
Participant Flow
Participant milestones
| Measure |
Vitamin E (1000 mg)
Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months.
Vitamin E \[(all-rac)-α-tocopheryl acetate\]: Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months
|
DHA EE (1.89 g)
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
DHA EE (1.89 g) and Vitamin E (1000 mg)
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
67
|
70
|
|
Overall Study
COMPLETED
|
26
|
30
|
61
|
60
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
6
|
10
|
Reasons for withdrawal
| Measure |
Vitamin E (1000 mg)
Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months.
Vitamin E \[(all-rac)-α-tocopheryl acetate\]: Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months
|
DHA EE (1.89 g)
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
DHA EE (1.89 g) and Vitamin E (1000 mg)
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
|
Overall Study
Early Termination
|
8
|
4
|
6
|
9
|
Baseline Characteristics
Vitamin E and DHA-EE on NAFLD - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial (PUVENAFLD)
Baseline characteristics by cohort
| Measure |
Vitamin E (1000 mg)
n=33 Participants
Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months.
Vitamin E \[(all-rac)-α-tocopheryl acetate\]: Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months
|
DHA EE (1.89 g)
n=34 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=66 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=70 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
Total
n=203 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.3 Years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
52.8 Years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
50.0 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
50.7 Years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
50.9 Years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
108 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
83 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
184 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
66 participants
n=5 Participants
|
70 participants
n=4 Participants
|
203 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
A change in liver fat content relative to baseline between Vitamin E and DHA EE vs placebo. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=60 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=57 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Hepatic Fat Fraction [%] Between of Vitamin E and DHA EE vs Placebo
|
-6.8 Percentage of liver fat
Standard Deviation 26.4
|
-8.2 Percentage of liver fat
Standard Deviation 18.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Change in liver fat content relative to baseline between Vitamin E vs placebo arm. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=26 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=57 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Hepatic Fat Fraction [%] Between Vitamin E vs Placebo Arm
|
-10.4 Percentage of liver fat
Standard Deviation 15.7
|
-8.2 Percentage of liver fat
Standard Deviation 18.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Change in liver fat content relative to baseline between DHA EE vs placebo arm. This will be measured by MRI-PDFF at baseline and after 6 months of intervention (value at 6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=29 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=57 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Hepatic Fat Fraction [%] Between DHA EE vs Placebo Arm
|
2.2 Percentage of liver fat
Standard Deviation 24.1
|
-8.2 Percentage of liver fat
Standard Deviation 18.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6 month measurements of waist circumference in the DHA EE and /or Vitamin E intervention over a 6 month period.
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=59 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=25 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=60 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist Circumference.
|
0.8 centimeters (cm)
Standard Deviation 6.5
|
-0.5 centimeters (cm)
Standard Deviation 4.9
|
-0.2 centimeters (cm)
Standard Deviation 6.0
|
0.8 centimeters (cm)
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month measurements of body weight in the DHA EE and /or Vitamin E intervention over a 6 month period.
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=61 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=26 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=32 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=60 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change After 6 Months of DHA EE and /or Vitamin E Intervention in the Anthropometric Measure, Bodyweight.
|
0.4 kilogram (kg)
Standard Deviation 3.7
|
0.5 kilogram (kg)
Standard Deviation 2.7
|
0.0 kilogram (kg)
Standard Deviation 4.1
|
-0.0 kilogram (kg)
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month measurements of waist-to-hip ratio (the circumference of the waist divided by the circumference of the hips) in the DHA EE and /or Vitamin E intervention over a 6 month period.
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=59 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=25 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=59 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Waist-to-hip Ratio .
|
0.0 ratio
Standard Deviation 0.0
|
-0.0 ratio
Standard Deviation 0.0
|
0.0 ratio
Standard Deviation 0.0
|
-0.0 ratio
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month measurements of body mass index (BMI) in the DHA EE and /or Vitamin E intervention over a 6 month period.
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=61 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=26 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=32 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=60 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change After 6 Months of DHA EE and/ or Vitamin E Intervention in the Anthropometric Measure, Body Mass Index (BMI)
|
0.1 kg/m^2
Standard Deviation 1.3
|
0.2 kg/m^2
Standard Deviation 1.0
|
-0.0 kg/m^2
Standard Deviation 1.5
|
-0.0 kg/m^2
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=58 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=24 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=61 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Insulin Levels to Determine Insulin Resistance
|
4.7 ulU/mL
Standard Deviation 38.7
|
-5.7 ulU/mL
Standard Deviation 47.8
|
9.9 ulU/mL
Standard Deviation 60.3
|
4.3 ulU/mL
Standard Deviation 43.9
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month liver enzymes: alanine transaminase (ALT) in the DHA EE and /or Vitamin E intervention over a 6 month period value at (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=123 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=54 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=63 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=125 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Liver Enzymes (ALT) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.
|
-4.6 U/L
Standard Deviation 53.9
|
-16.7 U/L
Standard Deviation 30.5
|
7.0 U/L
Standard Deviation 54.5
|
-6.8 U/L
Standard Deviation 32.3
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month liver enzymes: aspartate aminotransferase (AST) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=123 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=54 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=63 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=125 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Liver Enzymes (AST) in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.
|
-1.4 U/L
Standard Deviation 33.1
|
-6.4 U/L
Standard Deviation 25.1
|
2.9 U/L
Standard Deviation 35.4
|
-2.8 U/L
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month liver enzymes: Bilirubin in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=123 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=54 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=63 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=125 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Liver Enzymes Bilirubin in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.
|
0.1 mg/dL
Standard Deviation 0.2
|
-0.0 mg/dL
Standard Deviation 0.1
|
-0.0 mg/dL
Standard Deviation 0.2
|
0.1 mg/dL
Standard Deviation 0.2
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month liver enzymes: Alkaline Phosphatase in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=123 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=54 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=63 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=126 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Liver Enzymes Alkaline Phosphatase in the DHA EE and /or Vitamin E Intervention Over a 6 Month Period.
|
-4.1 U/L
Standard Deviation 15.6
|
-0.4 U/L
Standard Deviation 15.1
|
1.1 U/L
Standard Deviation 11.2
|
2.5 U/L
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
The formula for FIB-4 is: Age (\[yr\] x AST \[U/L\]) / ((PLT \[10(9)/L\]) x (ALT \[U/L\])(1/2)). A value of FIB-4 below 1.30 is considered as low risk for advanced fibrosis; a value of FIB-4 over 2.67 is considered as high risk for advanced fibrosis
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=58 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=25 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=58 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Fibrosis-4 (FIB-4) Score
|
-0.1 units on a scale
Standard Deviation 0.5
|
-0.2 units on a scale
Standard Deviation 0.5
|
-0.1 units on a scale
Standard Deviation 0.4
|
-0.0 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month plasma Vitamin E concentration in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=61 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=25 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=62 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Plasma Vitamin E Concentration
|
6972 ng/mL
Standard Deviation 7217.1
|
9949 ng/mL
Standard Deviation 10086.5
|
480.9 ng/mL
Standard Deviation 2898.5
|
148.0 ng/mL
Standard Deviation 2657.2
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month plasma DHA EE concentration in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=61 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=26 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=62 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Plasma DHA EE Concentration
|
41.6 ug/mL
Standard Deviation 51.9
|
0.6 ug/mL
Standard Deviation 24.9
|
52.8 ug/mL
Standard Deviation 51.6
|
-2.6 ug/mL
Standard Deviation 17.5
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month lipid profile (HDL-C) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=60 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=25 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=62 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Lipid Profile (HDL-C)
|
1.7 mg/dL
Standard Deviation 7.4
|
0.0 mg/dL
Standard Deviation 9.5
|
2.4 mg/dL
Standard Deviation 5.5
|
0.5 mg/dL
Standard Deviation 10.2
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month lipid profile (low density lipoprotein (LDL-C))in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=60 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=25 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=62 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Lipid Profile (Low Density Lipoprotein (LDL-C))
|
9.9 mg/dL
Standard Deviation 34.8
|
2.1 mg/dL
Standard Deviation 27.3
|
19.4 mg/dL
Standard Deviation 31.2
|
5.1 mg/dL
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month lipid profile (TGs)in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=60 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=25 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=62 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Lipid Profile (Triglycerides)
|
-23.1 mg/dL
Standard Deviation 78.5
|
2.0 mg/dL
Standard Deviation 107.3
|
-6.6 mg/dL
Standard Deviation 87.6
|
-21.4 mg/dL
Standard Deviation 93.9
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month lipid profile (oxidized LDL) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=60 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=25 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=62 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Lipid Profile (Oxidized LDL)
|
4.1 U/L
Standard Deviation 13.4
|
5.3 U/L
Standard Deviation 8.2
|
4.6 U/L
Standard Deviation 13.2
|
0.5 U/L
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month quality of life score (SF-36) in the DHA EE and /or Vitamin E intervention over a 6 month period (value at 6 months minus value at baseline). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=60 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=26 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=32 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=62 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Health Related Quality of Life Score (Short Form (SF-36))
Emotional Well-Being
|
-0.4 score on a scale
Standard Deviation 12.6
|
-1.9 score on a scale
Standard Deviation 10.7
|
2.3 score on a scale
Standard Deviation 13.0
|
0.5 score on a scale
Standard Deviation 16.1
|
|
Change in Health Related Quality of Life Score (Short Form (SF-36))
Pain
|
0.4 score on a scale
Standard Deviation 15.7
|
3.3 score on a scale
Standard Deviation 9.7
|
-0.8 score on a scale
Standard Deviation 20.3
|
3.3 score on a scale
Standard Deviation 18.7
|
|
Change in Health Related Quality of Life Score (Short Form (SF-36))
Role Limitations Due to Physical Health
|
-2.5 score on a scale
Standard Deviation 27.1
|
5.8 score on a scale
Standard Deviation 28.6
|
1.6 score on a scale
Standard Deviation 35.9
|
-4.4 score on a scale
Standard Deviation 24.2
|
|
Change in Health Related Quality of Life Score (Short Form (SF-36))
Social Functioning
|
1.9 score on a scale
Standard Deviation 16.4
|
-1.0 score on a scale
Standard Deviation 20.3
|
0.0 score on a scale
Standard Deviation 16.8
|
-1.6 score on a scale
Standard Deviation 17.0
|
|
Change in Health Related Quality of Life Score (Short Form (SF-36))
Energy/Fatigue
|
0.5 score on a scale
Standard Deviation 16.4
|
4.6 score on a scale
Standard Deviation 11.1
|
-1.4 score on a scale
Standard Deviation 17.0
|
0.8 score on a scale
Standard Deviation 17.5
|
|
Change in Health Related Quality of Life Score (Short Form (SF-36))
General Health
|
-0.4 score on a scale
Standard Deviation 15.2
|
0.4 score on a scale
Standard Deviation 10.0
|
2.8 score on a scale
Standard Deviation 14.7
|
-2.7 score on a scale
Standard Deviation 15.0
|
|
Change in Health Related Quality of Life Score (Short Form (SF-36))
Physical Functioning
|
-1.3 score on a scale
Standard Deviation 21.5
|
1.5 score on a scale
Standard Deviation 11.5
|
0.3 score on a scale
Standard Deviation 18.0
|
0.8 score on a scale
Standard Deviation 15.2
|
|
Change in Health Related Quality of Life Score (Short Form (SF-36))
Role Limitations Due to Emotional Problems
|
-0.6 score on a scale
Standard Deviation 33.9
|
7.7 score on a scale
Standard Deviation 21.7
|
0.0 score on a scale
Standard Deviation 22.4
|
-3.2 score on a scale
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month dietary intake levels of LC-PUFA (i.e. DHA and EPA) as measured by the Food Frequency Questionnaire (FFQ)in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=61 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=26 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=34 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=70 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Dietary Intake Levels of Long-chain Polyunsaturated Fatty Acids (LC-PUFA ) (i.e. DHA and EPA) as Measured by the Food Frequency Questionnaire (FFQ)
FFQ DHA
|
2.3 mg per day
Standard Deviation 39.7
|
4.4 mg per day
Standard Deviation 14.9
|
-0.7 mg per day
Standard Deviation 8.5
|
-1.6 mg per day
Standard Deviation 12.5
|
|
Change in Dietary Intake Levels of Long-chain Polyunsaturated Fatty Acids (LC-PUFA ) (i.e. DHA and EPA) as Measured by the Food Frequency Questionnaire (FFQ)
FFQ EPA
|
0.7 mg per day
Standard Deviation 19.7
|
2.4 mg per day
Standard Deviation 9.4
|
-0.6 mg per day
Standard Deviation 4.8
|
-0.8 mg per day
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month inflammatory markers (cytokeratin 18) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=58 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=25 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=31 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=61 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Inflammatory Markers (Cytokeratin 18 (CK-18))
|
-17.7 U/L
Standard Deviation 241.5
|
-26.8 U/L
Standard Deviation 215.7
|
37.3 U/L
Standard Deviation 284.3
|
61 U/L
Standard Deviation 15.1
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month inflammatory markers (IL-1β) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=55 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=22 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=29 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=56 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Inflammatory Markers (IL-1β)
|
0.0 pg/mL
Standard Deviation 0.8
|
-0.1 pg/mL
Standard Deviation 1.1
|
0.2 pg/mL
Standard Deviation 1.3
|
-0.4 pg/mL
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants analyzed varies from participant workflow due to inconsistencies in what was able to be collected at differing sites and timepoints
Evaluation of baseline and 6-month inflammatory markers (TNFα) in the DHA EE and /or Vitamin E intervention over a 6 month period (6 months minus value at baseline).
Outcome measures
| Measure |
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=55 Participants
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=22 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
DHA EE (1.89 g)
n=29 Participants
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
Placebo
n=56 Participants
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Change in Inflammatory Markers (TNFα)
|
-1.3 pg/mL
Standard Deviation 3.4
|
-0.2 pg/mL
Standard Deviation 2.5
|
-0.3 pg/mL
Standard Deviation 2.9
|
-0.5 pg/mL
Standard Deviation 3.0
|
Adverse Events
Vitamin E (1000 mg)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
DHA EE (1.89 g)
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
DHA EE (1.89 g) and Vitamin E (1000 mg)
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 25 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Vitamin E (1000 mg)
n=34 participants at risk
Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months.
Vitamin E \[(all-rac)-α-tocopheryl acetate\]: Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months
|
DHA EE (1.89 g)
n=34 participants at risk
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=67 participants at risk
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=70 participants at risk
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
General disorders
Chest pain
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
Other adverse events
| Measure |
Vitamin E (1000 mg)
n=34 participants at risk
Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months.
Vitamin E \[(all-rac)-α-tocopheryl acetate\]: Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months
|
DHA EE (1.89 g)
n=34 participants at risk
DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months).
Omega-3 fatty acid (DHA EE): DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
|
DHA EE (1.89 g) and Vitamin E (1000 mg)
n=67 participants at risk
DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months.
Omega-3 fatty acid (DHA EE) \& Vitamin E \[(all-rac)-α-tocopheryl acetate\]: DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
|
Placebo
n=70 participants at risk
Matching soybean oil placebo (3 capsules) of all arms daily for 6 months.
Placebo: Matching soybean placebo (3 capsules) of all arms daily for 6 months.
|
|---|---|---|---|---|
|
Nervous system disorders
Anxiety
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Hypertonic Bladder
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Nervous system disorders
Pyrexia
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
3.0%
2/67 • Number of events 2 • 6 months
|
0.00%
0/70 • 6 months
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
2.9%
1/34 • Number of events 1 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bell's Palsy
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
3.0%
2/67 • Number of events 2 • 6 months
|
0.00%
0/70 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Injury, poisoning and procedural complications
Food poisioning
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Eosinophilic esophagitis
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
5.9%
2/34 • Number of events 2 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
6.0%
4/67 • Number of events 4 • 6 months
|
4.3%
3/70 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
2.9%
1/34 • Number of events 1 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
6.0%
4/67 • Number of events 4 • 6 months
|
4.3%
3/70 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
abdominal pain lower
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
abdominal pain upper
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
1/34 • Number of events 1 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
3.0%
2/67 • Number of events 2 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Eructation
|
2.9%
1/34 • Number of events 1 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/34 • 6 months
|
5.9%
2/34 • Number of events 2 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
3.0%
2/67 • Number of events 2 • 6 months
|
0.00%
0/70 • 6 months
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
General disorders
Fatigue
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
General disorders
Edema peripheral
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
General disorders
Pain
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus type 2
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
General disorders
Headache
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
2.9%
2/70 • Number of events 2 • 6 months
|
|
General disorders
Migraine
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Ear and labyrinth disorders
Deafness
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Hepatobiliary disorders
Liver function test increased
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Infections and infestations
Ear infection
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Infections and infestations
Hordeolum
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Infections and infestations
Tooth infection
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Blood and lymphatic system disorders
Blood cholesterol increased
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Blood and lymphatic system disorders
Remnant hyperlipidemia
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Blood and lymphatic system disorders
Blood glucose increased
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.9%
1/34 • Number of events 1 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Eye disorders
Chalazion
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Vascular disorders
Neuropathy peripheral
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
2.9%
2/70 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
Neoplasm skin
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
General disorders
Insomnia
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
0.00%
0/70 • 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Desmoid tumor
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Hypothyroidism
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/34 • 6 months
|
2.9%
1/34 • Number of events 1 • 6 months
|
0.00%
0/67 • 6 months
|
1.4%
1/70 • Number of events 1 • 6 months
|
|
Reproductive system and breast disorders
Endometriosis
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
|
Infections and infestations
COVID-19
|
0.00%
0/34 • 6 months
|
5.9%
2/34 • Number of events 2 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
2.9%
2/70 • Number of events 2 • 6 months
|
|
Infections and infestations
Hepatitis C
|
0.00%
0/34 • 6 months
|
0.00%
0/34 • 6 months
|
1.5%
1/67 • Number of events 1 • 6 months
|
0.00%
0/70 • 6 months
|
Additional Information
Naga Chalasani, MD
Indiana University School of Medicine
Phone: (317) 278-0414
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place