VITamin D and OmegA-3 TriaL: Effects on Bone Structure and Architecture (VITAL)

Mass General Brigham

Status: Active, not recruiting

Conditions: Bone Health; Body Composition; Bone Density

Treatments: Dietary Supplement: Fish oil placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: omega-3 fatty acids (fish oil)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01747447

2012P000560

1R01AR059775-01A1 (U.S. NIH Grant/Contract)

5R01AR060574-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 771 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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771 participants in 4 patient groups, including a placebo group

Vitamin D placebo + fish oil placebo

Placebo Comparator group

Description:

Daily vitamin D placebo and daily fish oil placebo

Treatment:

Dietary Supplement: Vitamin D3 placebo

Dietary Supplement: Fish oil placebo

Vitamin D placebo + fish oil

Active Comparator group

Description:

Daily vitamin D placebo and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)

Treatment:

Dietary Supplement: omega-3 fatty acids (fish oil)

Dietary Supplement: Vitamin D3 placebo

Vitamin D + fish oil placebo

Active Comparator group

Description:

Daily vitamin D (2,000 IU/d) and daily fish oil placebo

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Fish oil placebo

Vitamin D + fish oil

Active Comparator group

Description:

Daily vitamin D (2,000 IU/d) and daily fish oil capsule (1 g/d; EPA + DHA in a 1.2:1 ratio)

Treatment:

Dietary Supplement: omega-3 fatty acids (fish oil)

Dietary Supplement: Vitamin D3