Bone Density, Body Composition, Bone Health
Conditions
Brief summary
The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or fish oil (1 gram of omega-3 fatty acids) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among a sub-cohort of 771 participants in VITAL and will test the efficacy and safety of high-dose vitamin D supplementation vs. placebo on skeletal health and body composition.
Detailed description
The VITAL: Effects on Bone Structure and Architecture is an ancillary study of the parent VITAL. This study has enrolled a sub-cohort of 771 VITAL participants at the NIH-sponsored Harvard Catalyst Clinical and Translational Science Center (CTSC). The following measurements will be performed at baseline and 2 years post-randomization to determine whether high-dose vitamin D supplementation vs. placebo: 1) produces small increases or reduces bone loss in spine, hip, and total body areal bone density as assessed by dual x-ray absorptiometry (DXA); 2) reduces bone turnover as assessed by biomarkers of bone resorption and formation; 3) improves (a) volumetric bone mineral density (vBMD) and measures of bone structure as assessed by peripheral quantitative computed tomography (pQCT) and (b) bone microarchitecture as assessed by high resolution pQCT (HR-pQCT) at the distal radius and tibia as well as trabecular bone score (TBS) at the spine; and 4) results in changes in body composition as assessed by DXA. Parallel assessments of the effects of omega-3 fatty acids will be performed. This study may elucidate the mechanisms through which high-dose vitamin D may prevent age-related fractures and provide new insights into the role of vitamin D on skeletal health and body composition. We are currently analyzing the effects of daily dietary supplements of fish oil (1 gram of omega-3 fatty acids) vs. placebo on skeletal health and body composition.
Interventions
DIETARY_SUPPLEMENTVitamin D3 placebo
Vitamin D placebo
DIETARY_SUPPLEMENTFish oil placebo
Fish oil placebo
DIETARY_SUPPLEMENTomega-3 fatty acids (fish oil)
Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
DIETARY_SUPPLEMENTVitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Sponsors
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double Blind
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Participants in VITAL (NCT 01169259) who meet the following criteria are eligible to participate in this ancillary study: * Those who are using bisphosphonates currently or within the past 2 years, or other bone-active medications currently or within the past year are not eligible for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Density | 2 years | 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. |
| Bone Turnover P1NP | 2 years | To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone formation (propeptide of type 1 collagen \[P1NP\]). |
| Bone Turnover Beta Crosslaps | 2 years | To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone resorption (beta crosslaps). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Structure | 2 years | To determine whether vitamin D and/or omega-3 supplementation results in changes in bone structure. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMeryl S LeBoff, M.D.
Brigham and Women's Hospital
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids Received active Vitamin D and active omega-3 fatty acids | 193 |
| ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids Received active Vitamin D and placebo omega-3 fatty acids | 195 |
| PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids Received placebo Vitamin D and active omega-3 fatty acids | 195 |
| PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids Received placebo Vitamin D and placebo omega-3 fatty acids | 188 |
| Total | 771 |
Baseline characteristics
| Characteristic | ACTIVE Vitamin D + PLACEBO Omega-3 Fatty Acids | ACTIVE Vitamin D + ACTIVE Omega-3 Fatty Acids | Total | PLACEBO Vitamin D + PLACEBO Omega-3 Fatty Acids | PLACEBO Vitamin D + ACTIVE Omega-3 Fatty Acids |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 78 Participants | 74 Participants | 305 Participants | 76 Participants | 77 Participants |
| Age, Categorical Between 18 and 65 years | 117 Participants | 119 Participants | 466 Participants | 112 Participants | 118 Participants |
| Age, Continuous | 63.7 Years STANDARD_DEVIATION 5.5 | 63.5 Years STANDARD_DEVIATION 6.5 | 63.8 Years STANDARD_DEVIATION 6.1 | 63.9 Years STANDARD_DEVIATION 6.3 | 64 Years STANDARD_DEVIATION 6.3 |
| Any Fracture History | 19 Participants | 13 Participants | 61 Participants | 14 Participants | 15 Participants |
| Baseline Calcium Supplement Use | 40 Participants | 29 Participants | 132 Participants | 27 Participants | 36 Participants |
| Baseline Free 25(OH)D | 5.6 pg/mL STANDARD_DEVIATION 1.8 | 5.9 pg/mL STANDARD_DEVIATION 1.8 | 5.8 pg/mL STANDARD_DEVIATION 7.4 | 5.8 pg/mL STANDARD_DEVIATION 1.7 | 6.0 pg/mL STANDARD_DEVIATION 2.1 |
| Baseline Total 25(OH)D | 26.9 ng/mL STANDARD_DEVIATION 9.2 | 27.1 ng/mL STANDARD_DEVIATION 8.5 | 27.7 ng/mL STANDARD_DEVIATION 9.1 | 28.0 ng/mL STANDARD_DEVIATION 8.5 | 28.9 ng/mL STANDARD_DEVIATION 10.1 |
| Baseline Vitamin D Use | 87 Participants | 70 Participants | 326 Participants | 77 Participants | 92 Participants |
| Body Mass Index | 26.9 kg/m^2 STANDARD_DEVIATION 4.7 | 27.5 kg/m^2 STANDARD_DEVIATION 4.7 | 27.2 kg/m^2 STANDARD_DEVIATION 4.8 | 26.8 kg/m^2 STANDARD_DEVIATION 4.6 | 27.7 kg/m^2 STANDARD_DEVIATION 5 |
| Current Smoking | 12 Participants | 14 Participants | 48 Participants | 13 Participants | 9 Participants |
| Diabetes History | 24 Participants | 20 Participants | 83 Participants | 21 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 10 Participants | 29 Participants | 10 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 183 Participants | 172 Participants | 703 Participants | 169 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 11 Participants | 39 Participants | 9 Participants | 10 Participants |
| Fat Mass Index | 10.2 kg/m^2 STANDARD_DEVIATION 3.9 | 10.3 kg/m^2 STANDARD_DEVIATION 4.1 | 10.3 kg/m^2 STANDARD_DEVIATION 3.9 | 9.9 kg/m^2 STANDARD_DEVIATION 3.6 | 10.7 kg/m^2 STANDARD_DEVIATION 3.8 |
| Leisure Time Physical Activity | 21.5 hr/wk | 22.7 hr/wk | 21.5 hr/wk | 20.4 hr/wk | 21.6 hr/wk |
| Parental History of Hip Fracture | 31 Participants | 23 Participants | 102 Participants | 24 Participants | 24 Participants |
| Race/Ethnicity, Customized African American | 17 Participants | 18 Participants | 67 Participants | 15 Participants | 17 Participants |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 1 Participants | 1 Participants | 5 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 4 Participants | 5 Participants | 15 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic (non-African American) | 3 Participants | 8 Participants | 26 Participants | 9 Participants | 6 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 162 Participants | 155 Participants | 630 Participants | 156 Participants | 157 Participants |
| Race/Ethnicity, Customized Other | 6 Participants | 3 Participants | 12 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 195 Participants | 193 Participants | 771 Participants | 188 Participants | 195 Participants |
| Sex: Female, Male Female | 91 Participants | 88 Participants | 360 Participants | 84 Participants | 97 Participants |
| Sex: Female, Male Male | 104 Participants | 105 Participants | 411 Participants | 104 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 8 / 388 | 3 / 383 | 3 / 388 | 8 / 383 | 2 / 193 | 6 / 195 | 1 / 195 | 2 / 188 |
| other Total, other adverse events | 301 / 388 | 280 / 383 | 286 / 388 | 295 / 383 | 152 / 193 | 149 / 195 | 134 / 195 | 146 / 188 |
| serious Total, serious adverse events | 39 / 388 | 37 / 383 | 35 / 388 | 41 / 383 | 20 / 193 | 19 / 195 | 15 / 195 | 22 / 188 |
Outcome results
Primary
Bone Turnover Beta Crosslaps
To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone resorption (beta crosslaps).
Time frame: 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Vitamin D | Bone Turnover Beta Crosslaps | Baseline beta crosslaps | 0.40 pg/mL | Standard Deviation 0.17 |
| Active Vitamin D | Bone Turnover Beta Crosslaps | Year 2 beta crosslaps | 0.40 pg/mL | Standard Deviation 0.17 |
| Vitamin D Placebo | Bone Turnover Beta Crosslaps | Year 2 beta crosslaps | 0.42 pg/mL | Standard Deviation 0.17 |
| Vitamin D Placebo | Bone Turnover Beta Crosslaps | Baseline beta crosslaps | 0.41 pg/mL | Standard Deviation 0.19 |
| Active Omega-3 Fatty Acids | Bone Turnover Beta Crosslaps | Baseline beta crosslaps | 0.41 pg/mL | Standard Deviation 0.19 |
| Active Omega-3 Fatty Acids | Bone Turnover Beta Crosslaps | Year 2 beta crosslaps | 0.40 pg/mL | Standard Deviation 0.17 |
| Omega-3 Fatty Acids Placebo | Bone Turnover Beta Crosslaps | Baseline beta crosslaps | 0.40 pg/mL | Standard Deviation 0.17 |
| Omega-3 Fatty Acids Placebo | Bone Turnover Beta Crosslaps | Year 2 beta crosslaps | 0.41 pg/mL | Standard Deviation 0.17 |
Primary
Bone Turnover P1NP
To determine whether vitamin D and/or omega-3 supplementation reduces bone turnover, assessed biomarkers of bone formation (propeptide of type 1 collagen \[P1NP\]).
Time frame: 2 years
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Vitamin D | Bone Turnover P1NP | Baseline P1NP | 49.99 ug/L | Standard Deviation 19.7 |
| Active Vitamin D | Bone Turnover P1NP | Year 2 P1NP | 48.28 ug/L | Standard Deviation 16.74 |
| Vitamin D Placebo | Bone Turnover P1NP | Year 2 P1NP | 49.04 ug/L | Standard Deviation 18.42 |
| Vitamin D Placebo | Bone Turnover P1NP | Baseline P1NP | 49.29 ug/L | Standard Deviation 19.47 |
| Active Omega-3 Fatty Acids | Bone Turnover P1NP | Baseline P1NP | 50.25 ug/L | Standard Deviation 20.83 |
| Active Omega-3 Fatty Acids | Bone Turnover P1NP | Year 2 P1NP | 48.00 ug/L | Standard Deviation 18.69 |
| Omega-3 Fatty Acids Placebo | Bone Turnover P1NP | Baseline P1NP | 48.99 ug/L | Standard Deviation 18.18 |
| Omega-3 Fatty Acids Placebo | Bone Turnover P1NP | Year 2 P1NP | 49.36 ug/L | Standard Deviation 16.35 |
Primary
Change in Bone Density
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.
Time frame: 2 years
Population: Some measurements were excluded due to metal artifacts, severe osteoarthritis, severe scoliosis, degenerative disc disease, and bilateral breast implants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Vitamin D | Change in Bone Density | Year 2 Femoral Neck Hip Areal Bone Mineral Density | 0.77 g/cm^2 | Standard Deviation 0.13 |
| Active Vitamin D | Change in Bone Density | Year 2 Total Hip Areal Bone Mineral Density | 0.93 g/cm^2 | Standard Deviation 0.15 |
| Active Vitamin D | Change in Bone Density | Baseline Total Hip Areal Bone Mineral Density | 0.94 g/cm^2 | Standard Deviation 0.15 |
| Active Vitamin D | Change in Bone Density | Baseline Spine Areal Bone Mineral Density | 1.02 g/cm^2 | Standard Deviation 0.16 |
| Active Vitamin D | Change in Bone Density | Year 2 Spine Areal Bone Mineral Density | 1.03 g/cm^2 | Standard Deviation 0.16 |
| Active Vitamin D | Change in Bone Density | Baseline Whole Body Areal Bone Mineral Density | 1.15 g/cm^2 | Standard Deviation 0.13 |
| Active Vitamin D | Change in Bone Density | Baseline Femoral Neck Hip Areal Bone Mineral Density | 0.77 g/cm^2 | Standard Deviation 0.13 |
| Active Vitamin D | Change in Bone Density | Year 2 Whole Body Areal Bone Mineral Density | 1.15 g/cm^2 | Standard Deviation 0.13 |
| Vitamin D Placebo | Change in Bone Density | Year 2 Total Hip Areal Bone Mineral Density | 0.94 g/cm^2 | Standard Deviation 0.15 |
| Vitamin D Placebo | Change in Bone Density | Year 2 Spine Areal Bone Mineral Density | 1.03 g/cm^2 | Standard Deviation 0.17 |
| Vitamin D Placebo | Change in Bone Density | Year 2 Whole Body Areal Bone Mineral Density | 1.15 g/cm^2 | Standard Deviation 0.13 |
| Vitamin D Placebo | Change in Bone Density | Baseline Total Hip Areal Bone Mineral Density | 0.93 g/cm^2 | Standard Deviation 0.15 |
| Vitamin D Placebo | Change in Bone Density | Baseline Femoral Neck Hip Areal Bone Mineral Density | 0.77 g/cm^2 | Standard Deviation 0.13 |
| Vitamin D Placebo | Change in Bone Density | Baseline Spine Areal Bone Mineral Density | 1.02 g/cm^2 | Standard Deviation 0.17 |
| Vitamin D Placebo | Change in Bone Density | Year 2 Femoral Neck Hip Areal Bone Mineral Density | 0.77 g/cm^2 | Standard Deviation 0.12 |
| Vitamin D Placebo | Change in Bone Density | Baseline Whole Body Areal Bone Mineral Density | 1.15 g/cm^2 | Standard Deviation 0.13 |
| Active 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 |
| Active Omega-3 Fatty Acids | Change in Bone Density | Baseline Spine Areal Bone Mineral Density | 1.02 g/cm^2 | Standard Deviation 0.16 |
| Active Omega-3 Fatty Acids | Change in Bone Density | Year 2 Spine Areal Bone Mineral Density | 1.03 g/cm^2 | Standard Deviation 0.17 |
| Active Omega-3 Fatty Acids | Change in Bone Density | Baseline Femoral Neck Hip Areal Bone Mineral Density | 0.77 g/cm^2 | Standard Deviation 0.13 |
| Active Omega-3 Fatty Acids | Change in Bone Density | Baseline Total Hip Areal Bone Mineral Density | 0.94 g/cm^2 | Standard Deviation 0.15 |
| Active Omega-3 Fatty Acids | Change in Bone Density | Year 2 Total Hip Areal Bone Mineral Density | 0.94 g/cm^2 | Standard Deviation 0.15 |
| Active Omega-3 Fatty Acids | Change in Bone Density | Baseline Whole Body Areal Bone Mineral Density | 1.15 g/cm^2 | Standard Deviation 0.13 |
| Active Omega-3 Fatty Acids | Change in Bone Density | Year 2 Whole Body Areal Bone Mineral Density | 1.15 g/cm^2 | Standard Deviation 0.13 |
| Omega-3 Fatty Acids Placebo | Change in Bone Density | Year 2 Total Hip Areal Bone Mineral Density | 0.93 g/cm^2 | Standard Deviation 0.15 |
| Omega-3 Fatty Acids Placebo | Change in Bone Density | Year 2 Spine Areal Bone Mineral Density | 1.03 g/cm^2 | Standard Deviation 0.17 |
| Omega-3 Fatty Acids Placebo | Change in Bone Density | Baseline Spine Areal Bone Mineral Density | 1.02 g/cm^2 | Standard Deviation 0.17 |
| Omega-3 Fatty Acids Placebo | Change in Bone Density | Year 2 Whole Body Areal Bone Mineral Density | 1.15 g/cm^2 | Standard Deviation 0.13 |
| Omega-3 Fatty Acids Placebo | Change in Bone Density | Baseline Whole Body Areal Bone Mineral Density | 1.15 g/cm^2 | Standard Deviation 0.13 |
| Omega-3 Fatty Acids Placebo | Change in Bone Density | Baseline Total Hip Areal Bone Mineral Density | 0.93 g/cm^2 | Standard Deviation 0.15 |
| Omega-3 Fatty Acids Placebo | Change in Bone Density | Year 2 Femoral Neck Hip Areal Bone Mineral Density | 0.76 g/cm^2 | Standard Deviation 0.12 |
| Omega-3 Fatty Acids Placebo | Change in Bone Density | Baseline Femoral Neck Hip Areal Bone Mineral Density | 0.76 g/cm^2 | Standard Deviation 0.12 |
Secondary
Change in Bone Structure
To determine whether vitamin D and/or omega-3 supplementation results in changes in bone structure.
Time frame: 2 years
Population: Some participants excluded due to motion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Vitamin D | Change in Bone Structure | Baseline Trabecular Volumetric Bone Mineral Density at the Radius | 196.45 mg/cm^3 | Standard Deviation 43.16 |
| Active Vitamin D | Change in Bone Structure | Year 2 Total Volumetric Bone Mineral Density at the Tibia | 296.76 mg/cm^3 | Standard Deviation 49.31 |
| Active Vitamin D | Change in Bone Structure | Year 2 Trabecular Volumetric Bone Mineral Density at the Radius | 199.56 mg/cm^3 | Standard Deviation 44.65 |
| Active Vitamin D | Change in Bone Structure | Year 2 Total Volumetric Bone Mineral Density at the Radius | 376.24 mg/cm^3 | Standard Deviation 74.48 |
| Active Vitamin D | Change in Bone Structure | Baseline Total Volumetric Bone Mineral Density at the Radius | 369.68 mg/cm^3 | Standard Deviation 69.48 |
| Active Vitamin D | Change in Bone Structure | Baseline Trabecular Volumetric Bone Mineral Density at the Tibia | 246.63 mg/cm^3 | Standard Deviation 40.74 |
| Active Vitamin D | Change in Bone Structure | Baseline Cortical Volumetric Bone Mineral Density at the Radius | 1197.75 mg/cm^3 | Standard Deviation 31.57 |
| Active Vitamin D | Change in Bone Structure | Year 2 Cortical Volumetric Bone Mineral Density at the Tibia | 1169.98 mg/cm^3 | Standard Deviation 32.74 |
| Active Vitamin D | Change in Bone Structure | Year 2 Trabecular Volumetric Bone Mineral Density at the Tibia | 249.30 mg/cm^3 | Standard Deviation 41.54 |
| Active Vitamin D | Change in Bone Structure | Baseline Cortical Volumetric Bone Mineral Density at the Tibia | 1167.39 mg/cm^3 | Standard Deviation 32.26 |
| Active Vitamin D | Change in Bone Structure | Baseline Total Volumetric Bone Mineral Density at the Tibia | 295.29 mg/cm^3 | Standard Deviation 48.05 |
| Active Vitamin D | Change in Bone Structure | Year 2 Cortical Volumetric Bone Mineral Density at the Radius | 1199.41 mg/cm^3 | Standard Deviation 33.69 |
| Vitamin D Placebo | Change in Bone Structure | Baseline Total Volumetric Bone Mineral Density at the Radius | 373.90 mg/cm^3 | Standard Deviation 72.5 |
| Vitamin D Placebo | Change in Bone Structure | Year 2 Trabecular Volumetric Bone Mineral Density at the Radius | 205.11 mg/cm^3 | Standard Deviation 46.02 |
| Vitamin D Placebo | Change in Bone Structure | Baseline Cortical Volumetric Bone Mineral Density at the Radius | 1196.98 mg/cm^3 | Standard Deviation 30.82 |
| Vitamin D Placebo | Change in Bone Structure | Year 2 Cortical Volumetric Bone Mineral Density at the Radius | 1201.55 mg/cm^3 | Standard Deviation 30.1 |
| Vitamin D Placebo | Change in Bone Structure | Year 2 Total Volumetric Bone Mineral Density at the Tibia | 303.21 mg/cm^3 | Standard Deviation 48.76 |
| Vitamin D Placebo | Change in Bone Structure | Year 2 Total Volumetric Bone Mineral Density at the Radius | 382.25 mg/cm^3 | Standard Deviation 71.68 |
| Vitamin D Placebo | Change in Bone Structure | Baseline Trabecular Volumetric Bone Mineral Density at the Radius | 202.80 mg/cm^3 | Standard Deviation 46.07 |
| Vitamin D Placebo | Change in Bone Structure | Baseline Total Volumetric Bone Mineral Density at the Tibia | 299.23 mg/cm^3 | Standard Deviation 49.29 |
| Vitamin D Placebo | Change in Bone Structure | Baseline Trabecular Volumetric Bone Mineral Density at the Tibia | 250.14 mg/cm^3 | Standard Deviation 42.28 |
| Vitamin D Placebo | Change in Bone Structure | Year 2 Trabecular Volumetric Bone Mineral Density at the Tibia | 254.07 mg/cm^3 | Standard Deviation 42.02 |
| Vitamin D Placebo | Change in Bone Structure | Baseline Cortical Volumetric Bone Mineral Density at the Tibia | 1162.02 mg/cm^3 | Standard Deviation 30.38 |
| Vitamin D Placebo | Change in Bone Structure | Year 2 Cortical Volumetric Bone Mineral Density at the Tibia | 1166.38 mg/cm^3 | Standard Deviation 30.62 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Baseline Trabecular Volumetric Bone Mineral Density at the Radius | 197.50 mg/cm^3 | Standard Deviation 46.07 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Year 2 Trabecular Volumetric Bone Mineral Density at the Radius | 200.12 mg/cm^3 | Standard Deviation 47.72 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Baseline Cortical Volumetric Bone Mineral Density at the Radius | 1197.87 mg/cm^3 | Standard Deviation 31.45 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Baseline Total Volumetric Bone Mineral Density at the Tibia | 297.55 mg/cm^3 | Standard Deviation 48.48 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Year 2 Cortical Volumetric Bone Mineral Density at the Radius | 1199.88 mg/cm^3 | Standard Deviation 32.7 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Year 2 Total Volumetric Bone Mineral Density at the Radius | 377.60 mg/cm^3 | Standard Deviation 70.42 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Baseline Trabecular Volumetric Bone Mineral Density at the Tibia | 248.45 mg/cm^3 | Standard Deviation 41.14 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Year 2 Cortical Volumetric Bone Mineral Density at the Tibia | 1166.61 mg/cm^3 | Standard Deviation 33.22 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Year 2 Trabecular Volumetric Bone Mineral Density at the Tibia | 252.11 mg/cm^3 | Standard Deviation 41.68 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Baseline Total Volumetric Bone Mineral Density at the Radius | 371.28 mg/cm^3 | Standard Deviation 68.72 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Year 2 Total Volumetric Bone Mineral Density at the Tibia | 300.91 mg/cm^3 | Standard Deviation 48.88 |
| Active Omega-3 Fatty Acids | Change in Bone Structure | Baseline Cortical Volumetric Bone Mineral Density at the Tibia | 1163.59 mg/cm^3 | Standard Deviation 33.09 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Baseline Cortical Volumetric Bone Mineral Density at the Tibia | 1165.81 mg/cm^3 | Standard Deviation 29.56 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Baseline Trabecular Volumetric Bone Mineral Density at the Radius | 201.78 mg/cm^3 | Standard Deviation 43.2 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Year 2 Trabecular Volumetric Bone Mineral Density at the Radius | 204.69 mg/cm^3 | Standard Deviation 42.67 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Year 2 Trabecular Volumetric Bone Mineral Density at the Tibia | 251.15 mg/cm^3 | Standard Deviation 42.01 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Year 2 Total Volumetric Bone Mineral Density at the Radius | 380.98 mg/cm^3 | Standard Deviation 75.98 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Year 2 Cortical Volumetric Bone Mineral Density at the Tibia | 1169.90 mg/cm^3 | Standard Deviation 30.06 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Year 2 Cortical Volumetric Bone Mineral Density at the Radius | 1201.16 mg/cm^3 | Standard Deviation 31.1 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Year 2 Total Volumetric Bone Mineral Density at the Tibia | 298.90 mg/cm^3 | Standard Deviation 49.41 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Baseline Total Volumetric Bone Mineral Density at the Radius | 372.29 mg/cm^3 | Standard Deviation 73.35 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Baseline Total Volumetric Bone Mineral Density at the Tibia | 296.96 mg/cm^3 | Standard Deviation 48.94 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Baseline Trabecular Volumetric Bone Mineral Density at the Tibia | 248.31 mg/cm^3 | Standard Deviation 41.98 |
| Omega-3 Fatty Acids Placebo | Change in Bone Structure | Baseline Cortical Volumetric Bone Mineral Density at the Radius | 1196.85 mg/cm^3 | Standard Deviation 30.93 |
Other Pre-specified
Body Composition
To 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.
Time frame: 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Vitamin D | Body Composition | Fat Mass Index | 10.26 kg/m^2 | Standard Deviation 4.04 |
| Active Vitamin D | Body Composition | Lean Mass Index | 16.46 kg/m^2 | Standard Deviation 2.34 |
| Active Vitamin D | Body Composition | Body Mass Index | 28.29 kg/m^2 | Standard Deviation 5.24 |
| Vitamin D Placebo | Body Composition | Body Mass Index | 28.32 kg/m^2 | Standard Deviation 5.05 |
| Vitamin D Placebo | Body Composition | Fat Mass Index | 10.28 kg/m^2 | Standard Deviation 3.74 |
| Vitamin D Placebo | Body Composition | Lean Mass Index | 16.46 kg/m^2 | Standard Deviation 2.54 |
| Active Omega-3 Fatty Acids | Body Composition | Fat Mass Index | 10.49 kg/m^2 | Standard Deviation 3.98 |
| Active Omega-3 Fatty Acids | Body Composition | Body Mass Index | 28.65 kg/m^2 | Standard Deviation 5.15 |
| Active Omega-3 Fatty Acids | Body Composition | Lean Mass Index | 16.59 kg/m^2 | Standard Deviation 2.42 |
| Omega-3 Fatty Acids Placebo | Body Composition | Fat Mass Index | 10.05 kg/m^2 | Standard Deviation 3.79 |
| Omega-3 Fatty Acids Placebo | Body Composition | Lean Mass Index | 16.33 kg/m^2 | Standard Deviation 2.46 |
| Omega-3 Fatty Acids Placebo | Body Composition | Body Mass Index | 27.96 kg/m^2 | Standard Deviation 5.12 |