Vitamin D and Omega-3 Adiposity Trial (VITAL Adiposity)

Mass General Brigham

Status

Unknown

Conditions

Adiposity

Treatments

Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day

Drug: omega-3 fatty acids (fish oil)

Study type

Interventional

Funder types

Other

Identifiers

NCT01785004

2012P001304

12GRNT11980009 (Other Grant/Funding Number)

Details and patient eligibility

About

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is a randomized clinical trial in 20,000 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (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 (VITAL Adiposity) is being conducted among participants in VITAL and will examine the effect of vitamin D or fish oil on changes in body composition and adiposity (baseline compared to 2 year, as measured by anthropometric indices, total and regional body fat and adipokines) and assess whether changes in cardiovascular risk factors (lipids, glucose tolerance, blood pressure) are mediated by these parameters. How achieved 25(OH)D levels are affected by body composition and body mass will also be assessed.

Full description

Observational studies suggest that low 25-hydroxyvitamin D (25(OH)D) levels are associated with high BMI and fat mass (FM), but it is unknown whether vitamin D supplementation can alter body composition or adiposity. Despite enthusiasm for the use of vitamin D supplements to reduce FM, the hypothesis that vitamin D can modify adiposity remains unproven. Finding strategies to prevent obesity is of critical public health importance due to the high prevalence of overweight/obesity and its role in causing diabetes, hypertension, dyslipidemia, cardiovascular disease (CVD), among others. Observational studies also link low 25(OH)D levels to CVD risk factors related to obesity, but sequestration of vitamin D in fat tissue may be a confounding factor. The effects of vitamin D supplementation on body composition, adiposity and CVD risk factors are best tested in a randomized clinical trial (RCT), and according to the Institute of Medicine (IOM) 2011 report, more data from randomized clinical trials on these outcomes are needed. Previous trials of vitamin D have been limited by the inability to separate effects of supplemental calcium from vitamin D, small sample size, insufficient vitamin D dose, failure to monitor 25(OH)D levels or inadequate ascertainment of body composition. The NIH-funded VITamin D and OmegA-3 TriaL (VITAL) (1 U01 CA138962) affords a unique and cost-effective opportunity to investigate the effect of vitamin D on changes in body composition and to assess whether changes in CVD risk factors are mediated, at least in part, by these parameters. VITAL is a large-scale, randomized, primary prevention trial testing 2000 IU/d vitamin D3 (cholecalciferol) and 1 g/day omega-3 fatty acids (840 mg EPA+DHA in 1.3:1 ratio) in a 2x2 factorial design among 20,000 men and women (≥50 and ≥55 years, respectively), with mean participant follow-up of 5 years for CVD and cancer. This ancillary study will address understudied areas and two overarching hypotheses that vitamin D supplementation (1) lowers total and regional (trunkal and abdominal/androidal) body fat as measured by dual x-ray absorptiometry (DXA) scans, improving biomarkers of adiposity (leptin, adiponectin) and (2) impacts CVD risk factors, at least in part through adiposity. The investigators also seek to define how circulating achieved 25(OH)D levels, due to supplementation, may be affected by body composition and BMI, thus elucidating how adiposity, BMI, and body composition (total and regional) may influence vitamin D intake needs in the population. To critically evaluate these hypotheses, the investigators will examine a representative, randomized subcohort of 1000 racially diverse VITAL participants (25% African American) over two years.

Enrollment

600 estimated patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants in VITAL (NCT 01169259) who are willing to participate in this ancillary study and undergo DXA evaluation (baseline and 2 years)

Exclusion criteria

Inability to travel to the Clinical and Translational Science Center in Boston where imaging, anthropometric measurements, and blood work will be performed.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Quadruple Blind

600 participants in 4 patient groups, including a placebo group

Vitamin D + fish oil

Active Comparator group

Description:

Vitamin D3 (cholecalciferol), 2000 IU per day and 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])

Treatment:

Drug: omega-3 fatty acids (fish oil)

Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day

Vitamin D + fish oil placebo

Active Comparator group

Description:

Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo

Treatment:

Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day

Vitamin D placebo + fish oil

Active Comparator group

Description: