VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL) (VITAL)
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| ClinicalTrials.gov Identifier: NCT01747447 |
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Recruitment Status :
Active, not recruiting
First Posted : December 11, 2012
Results First Posted : March 29, 2021
Last Update Posted : December 14, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bone Density Body Composition Bone Health | Dietary Supplement: Vitamin D3 placebo Dietary Supplement: Fish oil placebo Dietary Supplement: omega-3 fatty acids (fish oil) Dietary Supplement: Vitamin D3 | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 771 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | Double Blind |
| Primary Purpose: | Prevention |
| Official Title: | VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture |
| Actual Study Start Date : | August 2012 |
| Actual Primary Completion Date : | December 2017 |
| Estimated Study Completion Date : | June 2024 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Vitamin D placebo + fish oil placebo
Daily vitamin D placebo and daily fish oil placebo
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Dietary Supplement: Vitamin D3 placebo
Vitamin D placebo Dietary Supplement: Fish oil placebo Fish oil placebo |
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Active Comparator: Vitamin D placebo + fish oil
Daily vitamin D placebo and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)
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Dietary Supplement: Vitamin D3 placebo
Vitamin D placebo Dietary Supplement: omega-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]). |
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Active Comparator: Vitamin D + fish oil placebo
Daily vitamin D (2,000 IU/d) and daily fish oil placebo
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Dietary Supplement: Fish oil placebo
Fish oil placebo Dietary Supplement: Vitamin D3 Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Name: cholecalciferol |
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Active Comparator: Vitamin D + fish oil
Daily vitamin D (2,000 IU/d) and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)
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Dietary Supplement: omega-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 Supplement: Vitamin D3 Vitamin D3 (cholecalciferol), 2000 IU per day.
Other Name: cholecalciferol |
- Change in Bone Density [ Time Frame: 2 years ]To determine whether vitamin D 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 [ Time Frame: 2 years ]To determine whether vitamin D supplementation reduces bone turnover, assessed biomarkers of bone resorption (Collagen Type 1 c-telopeptide) and bone formation (propeptide of type 1 collagen). We are still finalizing analyses for biomarkers of bone resorption (Collagen Type 1 c-telopeptide) and bone formation (propeptide of type 1 collagen). The analyses for the bone turnover outcome were completed after the change in bone density and change in bone structure measures were finalized and reported. We have completed the assays for the biomarkers of bone resorption and are currently in the process of working with our programmers to have these assays analyzed within the next year. Due to a research lab closure, we were required to use institutional funds to cover the cost, resulting in delays in the publication of these analyses.
- Change in Bone Structure [ Time Frame: 2 years ]To determine whether vitamin D supplementation results in changes in bone structure.
- Body Composition [ Time Frame: 2 years ]To determine whether vitamin D 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.
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01747447
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: | Meryl S LeBoff, M.D. | Brigham and Women's Hospital |
Documents provided by Meryl LeBoff, Brigham and Women's Hospital:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Meryl LeBoff, Director of Skeletal Health and Osteoporosis Center, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01747447 |
| Other Study ID Numbers: |
2012P000560 1R01AR059775-01A1 ( U.S. NIH Grant/Contract ) 5R01AR060574-03 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 11, 2012 Key Record Dates |
| Results First Posted: | March 29, 2021 |
| Last Update Posted: | December 14, 2022 |
| Last Verified: | December 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Vitamin D Ergocalciferols Cholecalciferol Vitamins |
Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |