Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2R01AR059775-06A1 | U.S. NIH Grant/Contract | View source | |
| 5R01AR060574-03 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
Not provided
Not provided
Not provided
Not provided
Vitamin D supplements are widely promoted for bone health. Both vitamin D and vitamin K are important for deposition of calcium in bone, but little is known about the relationship of vitamin K status and bone health.
The goal of VITAL: Interrelationship of Vitamin D and Vitamin K on Bone is to test whether vitamin K status is associated with incident fractures in a case-cohort design or modifies the randomized effects of vitamin D supplementation vs. placebo on 2-year changes in bone density and structure outcomes.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D placebo + fish oil placebo | Placebo Comparator |
| |
| Vitamin D placebo + fish oil | Active Comparator |
| |
| Vitamin D + fish oil placebo | Active Comparator |
| |
| Vitamin D + fish oil | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 placebo | Dietary Supplement | Vitamin D placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Fractures | The effect of low vitamin K status (with or without vitamin D supplementation) on the number of new total, non-vertebral and hip fractures. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Areal Bone Density | The effect of low vitamin K status (with or without vitamin D supplementation) on changes in areal bone density at the spine and hip between baseline and two years post-randomization. | 2 years |
| Change in Volumetric Bone Mineral Density |
Not provided
Inclusion:
- Participants in VITAL (NCT 01169259) study who met the following criteria of the parent trial are eligible to participate in this ancillary study:
Exclusion:
- For aims 2 and 3, 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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Meryl S LeBoff, M.D. | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25623291 | Background | LeBoff MS, Yue AY, Copeland T, Cook NR, Buring JE, Manson JE. VITAL-Bone Health: rationale and design of two ancillary studies evaluating the effects of vitamin D and/or omega-3 fatty acid supplements on incident fractures and bone health outcomes in the VITamin D and OmegA-3 TriaL (VITAL). Contemp Clin Trials. 2015 Mar;41:259-68. doi: 10.1016/j.cct.2015.01.007. Epub 2015 Jan 24. | |
| 29408561 | Background | Donlon CM, LeBoff MS, Chou SH, Cook NR, Copeland T, Buring JE, Bubes V, Kotler G, Manson JE. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL): Effects on Bone Structure and Architecture. Contemp Clin Trials. 2018 Apr;67:56-67. doi: 10.1016/j.cct.2018.02.003. Epub 2018 Feb 23. |
| Label | URL |
|---|---|
| VITAL Study Website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fish oil placebo | Dietary Supplement | Fish oil placebo |
|
| Omega-3 fatty acids (fish oil) | Drug | 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]). |
|
| Vitamin D3 | Dietary Supplement | Vitamin D3 (cholecalciferol), 2000 IU per day. Other Names: cholecalciferol |
|
The effect of low vitamin K status (with or without vitamin D supplementation) on changes in total, trabecular and cortical volumetric bone mineral density (vBMD) between baseline and two years post-randomization. |
| 2 years |
| Change in Cortical Thickness | The effect of low vitamin K status (with or without vitamin D supplementation) on changes in cortical thickness assessed by peripheral quantitative computed tomography (pQCT) between baseline and two years post-randomization. | 2 years |
| Change in Bone Strength | The effect of low vitamin K status (with or without vitamin D supplementation) on changes in bone strength measures assessed by peripheral quantitative computed tomography (pQCT) between baseline and two years post-randomization. | 2 years |
| Change in Trabecular Bone Score | The effect of low vitamin K status (with or without vitamin D supplementation) on changes in trabecular bone score between baseline and two years post-randomization. | 2 years |
| Concentration of Urine Calcium | The effect of low vitamin K status (with or without vitamin D supplementation) on change in urine calcium excretion between baseline and two years post-randomization. | 2 years |
| 30022253 | Background | Goldman AL, Donlon CM, Cook NR, Manson JE, Buring JE, Copeland T, Yu CY, LeBoff MS. VITamin D and OmegA-3 TriaL (VITAL) bone health ancillary study: clinical factors associated with trabecular bone score in women and men. Osteoporos Int. 2018 Nov;29(11):2505-2515. doi: 10.1007/s00198-018-4633-3. Epub 2018 Jul 18. |
| 31923341 | Background | LeBoff MS, Chou SH, Murata EM, Donlon CM, Cook NR, Mora S, Lee IM, Kotler G, Bubes V, Buring JE, Manson JE. Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL). J Bone Miner Res. 2020 May;35(5):883-893. doi: 10.1002/jbmr.3958. Epub 2020 Jan 30. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |