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

NCT01785004 | Unknown

• 2 other identifiers: 2012P00130412GRNT11980009
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adiposity

Keywords

Adiposity; Body composition; Vitamin D; Adipokines; Omega-3 fatty acid

Outcome Measures

Primary Outcomes (1)

• Body Composition

  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.

  2 years

Secondary Outcomes (4)

• Anthropometric Measurements

  2 years

• Mediation of CVD risk factors by body composition

  2 years

• Adipokines

  2 years

• Achieved 25(OH)D level

  2 years

Study Arms (4)

Vitamin D + fish oil

ACTIVE COMPARATOR

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; Drug: omega-3 fatty acids (fish oil)

Vitamin D + fish oil placebo

ACTIVE COMPARATOR

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

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

Vitamin D placebo + fish oil

ACTIVE COMPARATOR

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)

Vitamin D placebo + fish oil placebo

PLACEBO COMPARATOR

Vitamin D placebo and fish oil placebo

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

Interventions

Vitamin D3 (cholecalciferol), 2000 IU per day DIETARY_SUPPLEMENT

cholecalciferol

Vitamin D + fish oil; Vitamin D + fish oil placebo; Vitamin D placebo + fish oil placebo

omega-3 fatty acids (fish oil) DRUG

Also known as: 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]).

Vitamin D + fish oil; Vitamin D placebo + fish oil; Vitamin D placebo + fish oil placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• American Heart Association: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity

Interventions

Cholecalciferol; Fatty Acids, Omega-3; Fish Oils; Omacor; Eicosapentaenoic Acid; Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fatty Acids, Unsaturated; Fatty Acids; Oils; Eicosanoids

Study Officials

• Jacqueline S. Danik, MD, DrPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: February 6, 2013
• Study Start: July 1, 2012
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

US (1)