Trial Outcomes & Findings for VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL) (NCT NCT01747447)
NCT ID: NCT01747447
Last Updated: 2026-02-09
Results Overview
To determine whether vitamin D and/or omega-3 supplementation produces small increases or reduces bone loss in spine, hip, and total body areal bone density, as assessed by DXA. Reported values are rounded up.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
771 participants
Primary outcome timeframe
2 years
Results posted on
2026-02-09
Participant Flow
The data were presented as Active Vitamin D + Active Omega-3 fatty acids, Active Vitamin D + Placebo Omega-3 fatty acids, Placebo Vitamin D + Active Omega-3 fatty acids, and Placebo Vitamin D + Placebo Omega-3 fatty acids.
Participant milestones
| Measure |
ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
Received active Vitamin D and active omega-3 fatty acids
|
ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
Received active Vitamin D and placebo omega-3 fatty acids
|
PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
Received placebo Vitamin D and active omega-3 fatty acids
|
PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
Received placebo Vitamin D and placebo omega-3 fatty acids
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
193
|
195
|
195
|
188
|
|
Overall Study
COMPLETED
|
170
|
177
|
176
|
164
|
|
Overall Study
NOT COMPLETED
|
23
|
18
|
19
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
Baseline characteristics by cohort
| Measure |
ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids
n=193 Participants
Received active Vitamin D and active omega-3 fatty acids
|
ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids
n=195 Participants
Received active Vitamin D and placebo omega-3 fatty acids
|
PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids
n=195 Participants
Received placebo Vitamin D and active omega-3 fatty acids
|
PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids
n=188 Participants
Received placebo Vitamin D and placebo omega-3 fatty acids
|
Total
n=771 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=195 Participants
|
0 Participants
n=188 Participants
|
0 Participants
n=771 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
119 Participants
n=193 Participants
|
117 Participants
n=195 Participants
|
118 Participants
n=195 Participants
|
112 Participants
n=188 Participants
|
466 Participants
n=771 Participants
|
|
Age, Categorical
>=65 years
|
74 Participants
n=193 Participants
|
78 Participants
n=195 Participants
|
77 Participants
n=195 Participants
|
76 Participants
n=188 Participants
|
305 Participants
n=771 Participants
|
|
Age, Continuous
|
63.5 Years
STANDARD_DEVIATION 6.5 • n=193 Participants
|
63.7 Years
STANDARD_DEVIATION 5.5 • n=195 Participants
|
64 Years
STANDARD_DEVIATION 6.3 • n=195 Participants
|
63.9 Years
STANDARD_DEVIATION 6.3 • n=188 Participants
|
63.8 Years
STANDARD_DEVIATION 6.1 • n=771 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=193 Participants
|
91 Participants
n=195 Participants
|
97 Participants
n=195 Participants
|
84 Participants
n=188 Participants
|
360 Participants
n=771 Participants
|
|
Sex: Female, Male
Male
|
105 Participants
n=193 Participants
|
104 Participants
n=195 Participants
|
98 Participants
n=195 Participants
|
104 Participants
n=188 Participants
|
411 Participants
n=771 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=193 Participants
|
3 Participants
n=195 Participants
|
6 Participants
n=195 Participants
|
10 Participants
n=188 Participants
|
29 Participants
n=771 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
172 Participants
n=193 Participants
|
183 Participants
n=195 Participants
|
179 Participants
n=195 Participants
|
169 Participants
n=188 Participants
|
703 Participants
n=771 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=193 Participants
|
9 Participants
n=195 Participants
|
10 Participants
n=195 Participants
|
9 Participants
n=188 Participants
|
39 Participants
n=771 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
155 Participants
n=190 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
162 Participants
n=193 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
157 Participants
n=189 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
156 Participants
n=183 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
630 Participants
n=755 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
|
Race/Ethnicity, Customized
African American
|
18 Participants
n=190 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
17 Participants
n=193 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
17 Participants
n=189 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
15 Participants
n=183 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
67 Participants
n=755 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
|
Race/Ethnicity, Customized
Hispanic (non-African American)
|
8 Participants
n=190 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
3 Participants
n=193 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
6 Participants
n=189 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
9 Participants
n=183 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
26 Participants
n=755 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
5 Participants
n=190 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
4 Participants
n=193 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
4 Participants
n=189 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
2 Participants
n=183 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
15 Participants
n=755 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
1 Participants
n=190 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
1 Participants
n=193 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
3 Participants
n=189 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
0 Participants
n=183 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
5 Participants
n=755 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=190 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
6 Participants
n=193 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
2 Participants
n=189 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
1 Participants
n=183 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
12 Participants
n=755 Participants • Of the total 771 participants, only 755 participants self-reported their race \& ethnic group.
|
|
Region of Enrollment
United States
|
193 Participants
n=193 Participants
|
195 Participants
n=195 Participants
|
195 Participants
n=195 Participants
|
188 Participants
n=188 Participants
|
771 Participants
n=771 Participants
|
|
Body Mass Index
|
27.5 kg/m^2
STANDARD_DEVIATION 4.7 • n=193 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 4.7 • n=195 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 5.0 • n=195 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 4.6 • n=188 Participants
|
27.2 kg/m^2
STANDARD_DEVIATION 4.8 • n=771 Participants
|
|
Fat Mass Index
|
10.3 kg/m^2
STANDARD_DEVIATION 4.1 • n=193 Participants
|
10.2 kg/m^2
STANDARD_DEVIATION 3.9 • n=195 Participants
|
10.7 kg/m^2
STANDARD_DEVIATION 3.8 • n=195 Participants
|
9.9 kg/m^2
STANDARD_DEVIATION 3.6 • n=188 Participants
|
10.3 kg/m^2
STANDARD_DEVIATION 3.9 • n=771 Participants
|
|
Leisure Time Physical Activity
|
22.7 hr/wk
n=193 Participants
|
21.5 hr/wk
n=195 Participants
|
21.6 hr/wk
n=195 Participants
|
20.4 hr/wk
n=188 Participants
|
21.5 hr/wk
n=771 Participants
|
|
Diabetes History
|
20 Participants
n=193 Participants
|
24 Participants
n=195 Participants
|
18 Participants
n=195 Participants
|
21 Participants
n=188 Participants
|
83 Participants
n=771 Participants
|
|
Current Smoking
|
14 Participants
n=193 Participants
|
12 Participants
n=195 Participants
|
9 Participants
n=195 Participants
|
13 Participants
n=188 Participants
|
48 Participants
n=771 Participants
|
|
Any Fracture History
|
13 Participants
n=193 Participants
|
19 Participants
n=195 Participants
|
15 Participants
n=195 Participants
|
14 Participants
n=188 Participants
|
61 Participants
n=771 Participants
|
|
Parental History of Hip Fracture
|
23 Participants
n=193 Participants
|
31 Participants
n=195 Participants
|
24 Participants
n=195 Participants
|
24 Participants
n=188 Participants
|
102 Participants
n=771 Participants
|
|
Baseline Calcium Supplement Use
|
29 Participants
n=193 Participants
|
40 Participants
n=195 Participants
|
36 Participants
n=195 Participants
|
27 Participants
n=188 Participants
|
132 Participants
n=771 Participants
|
|
Baseline Vitamin D Use
|
70 Participants
n=193 Participants
|
87 Participants
n=195 Participants
|
92 Participants
n=195 Participants
|
77 Participants
n=188 Participants
|
326 Participants
n=771 Participants
|
|
Baseline Total 25(OH)D
|
27.1 ng/mL
STANDARD_DEVIATION 8.5 • n=193 Participants
|
26.9 ng/mL
STANDARD_DEVIATION 9.2 • n=195 Participants
|
28.9 ng/mL
STANDARD_DEVIATION 10.1 • n=195 Participants
|
28.0 ng/mL
STANDARD_DEVIATION 8.5 • n=188 Participants
|
27.7 ng/mL
STANDARD_DEVIATION 9.1 • n=771 Participants
|
|
Baseline Free 25(OH)D
|
5.9 pg/mL
STANDARD_DEVIATION 1.8 • n=193 Participants
|
5.6 pg/mL
STANDARD_DEVIATION 1.8 • n=195 Participants
|
6.0 pg/mL
STANDARD_DEVIATION 2.1 • n=195 Participants
|
5.8 pg/mL
STANDARD_DEVIATION 1.7 • n=188 Participants
|
5.8 pg/mL
STANDARD_DEVIATION 7.4 • n=771 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Some measurements were excluded due to metal artifacts, severe osteoarthritis, severe scoliosis, degenerative disc disease, and bilateral breast implants.
To determine whether vitamin D and/or omega-3 supplementation produces small increases or reduces bone loss in spine, hip, and total body areal bone density, as assessed by DXA. Reported values are rounded up.
Outcome measures
| Measure |
Active Vitamin D
n=388 Participants
Received active Vitamin D
|
Vitamin D Placebo
n=383 Participants
Received placebo Vitamin D
|
Active Omega-3 Fatty Acids
n=388 Participants
Received active omega-3 fatty acids
|
Omega-3 Fatty Acids Placebo
n=383 Participants
Received placebo omega-3 fatty acids
|
|---|---|---|---|---|
|
Change in Bone Density
Year 2 Femoral Neck Hip Areal Bone Mineral Density
|
0.77 g/cm^2
Standard Deviation 0.13
|
0.77 g/cm^2
Standard Deviation 0.12
|
0.77 g/cm^2
Standard Deviation 0.13
|
0.76 g/cm^2
Standard Deviation 0.12
|
|
Change in Bone Density
Baseline Total Hip Areal Bone Mineral Density
|
0.94 g/cm^2
Standard Deviation 0.15
|
0.93 g/cm^2
Standard Deviation 0.15
|
0.94 g/cm^2
Standard Deviation 0.15
|
0.93 g/cm^2
Standard Deviation 0.15
|
|
Change in Bone Density
Year 2 Total Hip Areal Bone Mineral Density
|
0.93 g/cm^2
Standard Deviation 0.15
|
0.94 g/cm^2
Standard Deviation 0.15
|
0.94 g/cm^2
Standard Deviation 0.15
|
0.93 g/cm^2
Standard Deviation 0.15
|
|
Change in Bone Density
Baseline Whole Body Areal Bone Mineral Density
|
1.15 g/cm^2
Standard Deviation 0.13
|
1.15 g/cm^2
Standard Deviation 0.13
|
1.15 g/cm^2
Standard Deviation 0.13
|
1.15 g/cm^2
Standard Deviation 0.13
|
|
Change in Bone Density
Year 2 Whole Body Areal Bone Mineral Density
|
1.15 g/cm^2
Standard Deviation 0.13
|
1.15 g/cm^2
Standard Deviation 0.13
|
1.15 g/cm^2
Standard Deviation 0.13
|
1.15 g/cm^2
Standard Deviation 0.13
|
|
Change in Bone Density
Baseline Spine Areal Bone Mineral Density
|
1.02 g/cm^2
Standard Deviation 0.16
|
1.02 g/cm^2
Standard Deviation 0.17
|
1.02 g/cm^2
Standard Deviation 0.16
|
1.02 g/cm^2
Standard Deviation 0.17
|
|
Change in Bone Density
Year 2 Spine Areal Bone Mineral Density
|
1.03 g/cm^2
Standard Deviation 0.16
|
1.03 g/cm^2
Standard Deviation 0.17
|
1.03 g/cm^2
Standard Deviation 0.17
|
1.03 g/cm^2
Standard Deviation 0.17
|
|
Change in Bone Density
Baseline Femoral Neck Hip Areal Bone Mineral Density
|
0.77 g/cm^2
Standard Deviation 0.13
|
0.77 g/cm^2
Standard Deviation 0.13
|
0.77 g/cm^2
Standard Deviation 0.13
|
0.76 g/cm^2
Standard Deviation 0.12
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The original lab performing the assays for the bone turnover markers closed. Thus, the assays were payed for using divisional funds, resulting in a decrease in the total number of samples analyzed. The analysis population was a representative sample of the overall cohort.
To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone formation (propeptide of type 1 collagen \[P1NP\]).
Outcome measures
| Measure |
Active Vitamin D
n=200 Participants
Received active Vitamin D
|
Vitamin D Placebo
n=200 Participants
Received placebo Vitamin D
|
Active Omega-3 Fatty Acids
n=205 Participants
Received active omega-3 fatty acids
|
Omega-3 Fatty Acids Placebo
n=195 Participants
Received placebo omega-3 fatty acids
|
|---|---|---|---|---|
|
Bone Turnover P1NP
Baseline P1NP
|
49.99 ug/L
Standard Deviation 19.70
|
49.29 ug/L
Standard Deviation 19.47
|
50.25 ug/L
Standard Deviation 20.83
|
48.99 ug/L
Standard Deviation 18.18
|
|
Bone Turnover P1NP
Year 2 P1NP
|
48.28 ug/L
Standard Deviation 16.74
|
49.04 ug/L
Standard Deviation 18.42
|
48.00 ug/L
Standard Deviation 18.69
|
49.36 ug/L
Standard Deviation 16.35
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The original lab performing the assays for the bone turnover markers closed. Thus, the assays were payed for using divisional funds, resulting in a decrease in the total number of samples analyzed. The analysis population was a representative sample of the overall cohort.
To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone resorption (beta crosslaps).
Outcome measures
| Measure |
Active Vitamin D
n=200 Participants
Received active Vitamin D
|
Vitamin D Placebo
n=200 Participants
Received placebo Vitamin D
|
Active Omega-3 Fatty Acids
n=205 Participants
Received active omega-3 fatty acids
|
Omega-3 Fatty Acids Placebo
n=195 Participants
Received placebo omega-3 fatty acids
|
|---|---|---|---|---|
|
Bone Turnover Beta Crosslaps
Baseline beta crosslaps
|
0.40 pg/mL
Standard Deviation 0.17
|
0.41 pg/mL
Standard Deviation 0.19
|
0.41 pg/mL
Standard Deviation 0.19
|
0.40 pg/mL
Standard Deviation 0.17
|
|
Bone Turnover Beta Crosslaps
Year 2 beta crosslaps
|
0.40 pg/mL
Standard Deviation 0.17
|
0.42 pg/mL
Standard Deviation 0.17
|
0.40 pg/mL
Standard Deviation 0.17
|
0.41 pg/mL
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Some participants excluded due to motion
To determine whether vitamin D and/or omega-3 supplementation results in changes in bone structure.
Outcome measures
| Measure |
Active Vitamin D
n=388 Participants
Received active Vitamin D
|
Vitamin D Placebo
n=383 Participants
Received placebo Vitamin D
|
Active Omega-3 Fatty Acids
n=388 Participants
Received active omega-3 fatty acids
|
Omega-3 Fatty Acids Placebo
n=383 Participants
Received placebo omega-3 fatty acids
|
|---|---|---|---|---|
|
Change in Bone Structure
Baseline Total Volumetric Bone Mineral Density at the Radius
|
369.68 mg/cm^3
Standard Deviation 69.48
|
373.90 mg/cm^3
Standard Deviation 72.50
|
371.28 mg/cm^3
Standard Deviation 68.72
|
372.29 mg/cm^3
Standard Deviation 73.35
|
|
Change in Bone Structure
Year 2 Total Volumetric Bone Mineral Density at the Radius
|
376.24 mg/cm^3
Standard Deviation 74.48
|
382.25 mg/cm^3
Standard Deviation 71.68
|
377.60 mg/cm^3
Standard Deviation 70.42
|
380.98 mg/cm^3
Standard Deviation 75.98
|
|
Change in Bone Structure
Baseline Trabecular Volumetric Bone Mineral Density at the Radius
|
196.45 mg/cm^3
Standard Deviation 43.16
|
202.80 mg/cm^3
Standard Deviation 46.07
|
197.50 mg/cm^3
Standard Deviation 46.07
|
201.78 mg/cm^3
Standard Deviation 43.20
|
|
Change in Bone Structure
Year 2 Trabecular Volumetric Bone Mineral Density at the Radius
|
199.56 mg/cm^3
Standard Deviation 44.65
|
205.11 mg/cm^3
Standard Deviation 46.02
|
200.12 mg/cm^3
Standard Deviation 47.72
|
204.69 mg/cm^3
Standard Deviation 42.67
|
|
Change in Bone Structure
Baseline Cortical Volumetric Bone Mineral Density at the Radius
|
1197.75 mg/cm^3
Standard Deviation 31.57
|
1196.98 mg/cm^3
Standard Deviation 30.82
|
1197.87 mg/cm^3
Standard Deviation 31.45
|
1196.85 mg/cm^3
Standard Deviation 30.93
|
|
Change in Bone Structure
Year 2 Cortical Volumetric Bone Mineral Density at the Radius
|
1199.41 mg/cm^3
Standard Deviation 33.69
|
1201.55 mg/cm^3
Standard Deviation 30.10
|
1199.88 mg/cm^3
Standard Deviation 32.70
|
1201.16 mg/cm^3
Standard Deviation 31.10
|
|
Change in Bone Structure
Baseline Total Volumetric Bone Mineral Density at the Tibia
|
295.29 mg/cm^3
Standard Deviation 48.05
|
299.23 mg/cm^3
Standard Deviation 49.29
|
297.55 mg/cm^3
Standard Deviation 48.48
|
296.96 mg/cm^3
Standard Deviation 48.94
|
|
Change in Bone Structure
Year 2 Total Volumetric Bone Mineral Density at the Tibia
|
296.76 mg/cm^3
Standard Deviation 49.31
|
303.21 mg/cm^3
Standard Deviation 48.76
|
300.91 mg/cm^3
Standard Deviation 48.88
|
298.90 mg/cm^3
Standard Deviation 49.41
|
|
Change in Bone Structure
Baseline Trabecular Volumetric Bone Mineral Density at the Tibia
|
246.63 mg/cm^3
Standard Deviation 40.74
|
250.14 mg/cm^3
Standard Deviation 42.28
|
248.45 mg/cm^3
Standard Deviation 41.14
|
248.31 mg/cm^3
Standard Deviation 41.98
|
|
Change in Bone Structure
Year 2 Trabecular Volumetric Bone Mineral Density at the Tibia
|
249.30 mg/cm^3
Standard Deviation 41.54
|
254.07 mg/cm^3
Standard Deviation 42.02
|
252.11 mg/cm^3
Standard Deviation 41.68
|
251.15 mg/cm^3
Standard Deviation 42.01
|
|
Change in Bone Structure
Baseline Cortical Volumetric Bone Mineral Density at the Tibia
|
1167.39 mg/cm^3
Standard Deviation 32.26
|
1162.02 mg/cm^3
Standard Deviation 30.38
|
1163.59 mg/cm^3
Standard Deviation 33.09
|
1165.81 mg/cm^3
Standard Deviation 29.56
|
|
Change in Bone Structure
Year 2 Cortical Volumetric Bone Mineral Density at the Tibia
|
1169.98 mg/cm^3
Standard Deviation 32.74
|
1166.38 mg/cm^3
Standard Deviation 30.62
|
1166.61 mg/cm^3
Standard Deviation 33.22
|
1169.90 mg/cm^3
Standard Deviation 30.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 yearsTo determine whether vitamin D and/or omega-3 supplementation results in changes in body composition as assessed by DXA: total body fat and lean mass, and fat mass index and lean mass index, regional fat and lean mass and derived ratios.
Outcome measures
| Measure |
Active Vitamin D
n=388 Participants
Received active Vitamin D
|
Vitamin D Placebo
n=383 Participants
Received placebo Vitamin D
|
Active Omega-3 Fatty Acids
n=388 Participants
Received active omega-3 fatty acids
|
Omega-3 Fatty Acids Placebo
n=383 Participants
Received placebo omega-3 fatty acids
|
|---|---|---|---|---|
|
Body Composition
Body Mass Index
|
28.29 kg/m^2
Standard Deviation 5.24
|
28.32 kg/m^2
Standard Deviation 5.05
|
28.65 kg/m^2
Standard Deviation 5.15
|
27.96 kg/m^2
Standard Deviation 5.12
|
|
Body Composition
Fat Mass Index
|
10.26 kg/m^2
Standard Deviation 4.04
|
10.28 kg/m^2
Standard Deviation 3.74
|
10.49 kg/m^2
Standard Deviation 3.98
|
10.05 kg/m^2
Standard Deviation 3.79
|
|
Body Composition
Lean Mass Index
|
16.46 kg/m^2
Standard Deviation 2.34
|
16.46 kg/m^2
Standard Deviation 2.54
|
16.59 kg/m^2
Standard Deviation 2.42
|
16.33 kg/m^2
Standard Deviation 2.46
|
Adverse Events
Active Vitamin D
Serious events: 39 serious events
Other events: 301 other events
Deaths: 8 deaths
Vitamin D Placebo
Serious events: 37 serious events
Other events: 280 other events
Deaths: 3 deaths
Active Omega-3 Fatty Acids
Serious events: 35 serious events
Other events: 286 other events
Deaths: 3 deaths
Omega-3 Fatty Acids Placebo
Serious events: 41 serious events
Other events: 295 other events
Deaths: 8 deaths
Active Vitamin D/Active Omega-3 Fatty Acids
Serious events: 20 serious events
Other events: 152 other events
Deaths: 2 deaths
Active Vitamin D/Placebo Omega-3 Fatty Acids
Serious events: 19 serious events
Other events: 149 other events
Deaths: 6 deaths
Placebo Vitamin D/Active Omega-3 Fatty Acids
Serious events: 15 serious events
Other events: 134 other events
Deaths: 1 deaths
Placebo Vitamin D/Placebo Omega-3 Fatty Acids
Serious events: 22 serious events
Other events: 146 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Active Vitamin D
n=388 participants at risk
Received active Vitamin D
|
Vitamin D Placebo
n=383 participants at risk
Received placebo Vitamin D
|
Active Omega-3 Fatty Acids
n=388 participants at risk
Received active omega-3 fatty acids
|
Omega-3 Fatty Acids Placebo
n=383 participants at risk
Received placebo omega-3 fatty acids
|
Active Vitamin D/Active Omega-3 Fatty Acids
n=193 participants at risk
Received active vitamin D and active omega-3 fatty acids
|
Active Vitamin D/Placebo Omega-3 Fatty Acids
n=195 participants at risk
Received active vitamin D and placebo omega-3 fatty acids
|
Placebo Vitamin D/Active Omega-3 Fatty Acids
n=195 participants at risk
Received placebo vitamin D and active omega-3 fatty acids
|
Placebo Vitamin D/Placebo Omega-3 Fatty Acids
n=188 participants at risk
Received placebo vitamin D and placebo omega-3 fatty acids
|
|---|---|---|---|---|---|---|---|---|
|
General disorders
Malignant Cancer
|
5.7%
22/388 • Baseline - 2 years
|
5.0%
19/383 • Baseline - 2 years
|
3.9%
15/388 • Baseline - 2 years
|
6.8%
26/383 • Baseline - 2 years
|
4.7%
9/193 • Baseline - 2 years
|
6.7%
13/195 • Baseline - 2 years
|
3.1%
6/195 • Baseline - 2 years
|
6.9%
13/188 • Baseline - 2 years
|
|
Cardiac disorders
Major Cardiovascular Events
|
1.8%
7/388 • Baseline - 2 years
|
1.0%
4/383 • Baseline - 2 years
|
1.8%
7/388 • Baseline - 2 years
|
1.0%
4/383 • Baseline - 2 years
|
2.6%
5/193 • Baseline - 2 years
|
1.0%
2/195 • Baseline - 2 years
|
1.0%
2/195 • Baseline - 2 years
|
1.1%
2/188 • Baseline - 2 years
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
2.6%
10/388 • Baseline - 2 years
|
2.6%
10/383 • Baseline - 2 years
|
2.3%
9/388 • Baseline - 2 years
|
2.9%
11/383 • Baseline - 2 years
|
3.1%
6/193 • Baseline - 2 years
|
2.1%
4/195 • Baseline - 2 years
|
1.5%
3/195 • Baseline - 2 years
|
3.7%
7/188 • Baseline - 2 years
|
|
Endocrine disorders
Hypercalcemia
|
0.77%
3/388 • Baseline - 2 years
|
1.3%
5/383 • Baseline - 2 years
|
1.8%
7/388 • Baseline - 2 years
|
0.26%
1/383 • Baseline - 2 years
|
1.6%
3/193 • Baseline - 2 years
|
0.00%
0/195 • Baseline - 2 years
|
2.1%
4/195 • Baseline - 2 years
|
0.53%
1/188 • Baseline - 2 years
|
Other adverse events
| Measure |
Active Vitamin D
n=388 participants at risk
Received active Vitamin D
|
Vitamin D Placebo
n=383 participants at risk
Received placebo Vitamin D
|
Active Omega-3 Fatty Acids
n=388 participants at risk
Received active omega-3 fatty acids
|
Omega-3 Fatty Acids Placebo
n=383 participants at risk
Received placebo omega-3 fatty acids
|
Active Vitamin D/Active Omega-3 Fatty Acids
n=193 participants at risk
Received active vitamin D and active omega-3 fatty acids
|
Active Vitamin D/Placebo Omega-3 Fatty Acids
n=195 participants at risk
Received active vitamin D and placebo omega-3 fatty acids
|
Placebo Vitamin D/Active Omega-3 Fatty Acids
n=195 participants at risk
Received placebo vitamin D and active omega-3 fatty acids
|
Placebo Vitamin D/Placebo Omega-3 Fatty Acids
n=188 participants at risk
Received placebo vitamin D and placebo omega-3 fatty acids
|
|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Kidney Failure or Dialysis
|
0.26%
1/388 • Baseline - 2 years
|
0.00%
0/383 • Baseline - 2 years
|
0.26%
1/388 • Baseline - 2 years
|
0.00%
0/383 • Baseline - 2 years
|
0.52%
1/193 • Baseline - 2 years
|
0.00%
0/195 • Baseline - 2 years
|
0.00%
0/195 • Baseline - 2 years
|
0.00%
0/188 • Baseline - 2 years
|
|
Renal and urinary disorders
Blood in Urine
|
4.6%
18/388 • Baseline - 2 years
|
7.0%
27/383 • Baseline - 2 years
|
5.7%
22/388 • Baseline - 2 years
|
6.0%
23/383 • Baseline - 2 years
|
4.1%
8/193 • Baseline - 2 years
|
5.1%
10/195 • Baseline - 2 years
|
7.2%
14/195 • Baseline - 2 years
|
6.9%
13/188 • Baseline - 2 years
|
|
Skin and subcutaneous tissue disorders
Easy Bruising
|
16.0%
62/388 • Baseline - 2 years
|
15.9%
61/383 • Baseline - 2 years
|
15.2%
59/388 • Baseline - 2 years
|
16.7%
64/383 • Baseline - 2 years
|
15.0%
29/193 • Baseline - 2 years
|
16.9%
33/195 • Baseline - 2 years
|
15.4%
30/195 • Baseline - 2 years
|
16.5%
31/188 • Baseline - 2 years
|
|
General disorders
Frequent Nosebleeds
|
2.6%
10/388 • Baseline - 2 years
|
5.2%
20/383 • Baseline - 2 years
|
4.4%
17/388 • Baseline - 2 years
|
3.4%
13/383 • Baseline - 2 years
|
3.6%
7/193 • Baseline - 2 years
|
1.5%
3/195 • Baseline - 2 years
|
5.1%
10/195 • Baseline - 2 years
|
5.3%
10/188 • Baseline - 2 years
|
|
Gastrointestinal disorders
Stomach Pain
|
37.4%
145/388 • Baseline - 2 years
|
33.4%
128/383 • Baseline - 2 years
|
35.8%
139/388 • Baseline - 2 years
|
35.0%
134/383 • Baseline - 2 years
|
39.9%
77/193 • Baseline - 2 years
|
34.9%
68/195 • Baseline - 2 years
|
31.8%
62/195 • Baseline - 2 years
|
35.1%
66/188 • Baseline - 2 years
|
|
Gastrointestinal disorders
Nausea
|
22.7%
88/388 • Baseline - 2 years
|
20.1%
77/383 • Baseline - 2 years
|
20.6%
80/388 • Baseline - 2 years
|
22.2%
85/383 • Baseline - 2 years
|
22.3%
43/193 • Baseline - 2 years
|
23.1%
45/195 • Baseline - 2 years
|
19.0%
37/195 • Baseline - 2 years
|
21.3%
40/188 • Baseline - 2 years
|
|
Gastrointestinal disorders
Constipation
|
31.2%
121/388 • Baseline - 2 years
|
34.7%
133/383 • Baseline - 2 years
|
30.4%
118/388 • Baseline - 2 years
|
35.5%
136/383 • Baseline - 2 years
|
27.5%
53/193 • Baseline - 2 years
|
34.9%
68/195 • Baseline - 2 years
|
33.3%
65/195 • Baseline - 2 years
|
36.2%
68/188 • Baseline - 2 years
|
|
Endocrine disorders
Parathyroid Condition
|
0.26%
1/388 • Baseline - 2 years
|
1.0%
4/383 • Baseline - 2 years
|
0.77%
3/388 • Baseline - 2 years
|
0.52%
2/383 • Baseline - 2 years
|
0.00%
0/193 • Baseline - 2 years
|
0.51%
1/195 • Baseline - 2 years
|
1.5%
3/195 • Baseline - 2 years
|
0.53%
1/188 • Baseline - 2 years
|
|
Renal and urinary disorders
Kidney Stones
|
4.4%
17/388 • Baseline - 2 years
|
2.9%
11/383 • Baseline - 2 years
|
4.1%
16/388 • Baseline - 2 years
|
3.1%
12/383 • Baseline - 2 years
|
5.2%
10/193 • Baseline - 2 years
|
3.6%
7/195 • Baseline - 2 years
|
3.1%
6/195 • Baseline - 2 years
|
2.7%
5/188 • Baseline - 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place