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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jacqueline Suk Danik, MD, DrPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01785004
First received: January 23, 2013
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Adiposity
Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day
Drug: omega-3 fatty acids (fish oil)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Interrelationship of Vitamin D Supplementation, Adiposity and CVD Risk Factors in a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Body Composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will measure by DXA, changes in body composition (i) total body fat and lean mass, (ii) regional and standardized body fat and lean mass (trunkal, androidal (abdominal), appendicular (limb) and derived ratios (trunk/limb; android/gynoid)) among those randomized to vitamin D supplementation vs. those randomized to placebo.


Secondary Outcome Measures:
  • Anthropometric Measurements [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will perform and compare changes in anthropometric measurements, including BMI, waist circumference and waist-hip ratio.

  • Mediation of CVD risk factors by body composition [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will compare 2 year changes in CVD risk factors: (lipids [triglycerides, HDL, LDL]), glucose homeostasis (hemoglobin A1c, glucose, insulin, HOMA-IR) and blood pressure between treatment groups, and assess whether changes in body composition mediate any treatment effects.

  • Adipokines [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Among 200 participants, we will assess effect of vitamin D supplementation on adipokines to assess for 2-year changes among those randomized to supplementation vs. placebo.

  • Achieved 25(OH)D level [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    We will assess whether achieved 25(OH)D levels with supplementation are affected by baseline and change in body composition and BMI.


Estimated Enrollment: 600
Study Start Date: July 2012
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D + fish oil
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])
Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day
cholecalciferol
Drug: omega-3 fatty acids (fish oil)
Other Names:
  • Omacor, 1 capsule a day.
  • Each capsure of Omacor contains 840 milligrams of marine omega-3 fatty acid
  • (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
Active Comparator: Vitamin D + fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo
Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day
cholecalciferol
Active Comparator: Vitamin D placebo + fish oil
Vitamin D placebo and 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
Drug: omega-3 fatty acids (fish oil)
Other Names:
  • Omacor, 1 capsule a day.
  • Each capsure of Omacor contains 840 milligrams of marine omega-3 fatty acid
  • (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
Placebo Comparator: Vitamin D placebo + fish oil placebo
Vitamin D placebo and fish oil placebo

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785004

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Brigham and Women's Hospital
American Heart Association
Investigators
Principal Investigator: Jacqueline S. Danik, MD, DrPH Brigham and Women's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Jacqueline Suk Danik, MD, DrPH, Principal Investigator, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01785004     History of Changes
Other Study ID Numbers: 2012P001304, 12GRNT11980009
Study First Received: January 23, 2013
Last Updated: February 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
Adiposity
Body composition
Vitamin D
Adipokines
Omega-3 fatty acid

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Vitamin D
Ergocalciferols
Vitamins
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014