- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01785004
Vitamin D and Omega-3 Adiposity Trial (VITAL Adiposity) (VITAL)
April 11, 2021 updated by: Jacqueline Suk Danik, MD, DrPH, Brigham and Women's Hospital
Interrelationship of Vitamin D Supplementation, Adiposity and CVD Risk Factors in a Randomized Clinical Trial
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Brigham and Women's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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])
|
cholecalciferol
Other Names:
|
Active Comparator: Vitamin D + fish oil placebo
Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo
|
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])
|
Other Names:
|
Placebo Comparator: Vitamin D placebo + fish oil placebo
Vitamin D placebo and fish oil placebo
|
cholecalciferol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Composition
Time Frame: 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometric Measurements
Time Frame: 2 years
|
We will perform and compare changes in anthropometric measurements, including BMI, waist circumference and waist-hip ratio.
|
2 years
|
Mediation of CVD risk factors by body composition
Time Frame: 2 years
|
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.
|
2 years
|
Adipokines
Time Frame: 2 years
|
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.
|
2 years
|
Achieved 25(OH)D level
Time Frame: 2 years
|
We will assess whether achieved 25(OH)D levels with supplementation are affected by baseline and change in body composition and BMI.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jacqueline S. Danik, MD, DrPH, Brigham and Women's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
January 23, 2013
First Submitted That Met QC Criteria
February 5, 2013
First Posted (Estimate)
February 6, 2013
Study Record Updates
Last Update Posted (Actual)
April 13, 2021
Last Update Submitted That Met QC Criteria
April 11, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012P001304
- 12GRNT11980009 (Other Grant/Funding Number: AHA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adiposity
-
Johns Hopkins UniversityCompleted
-
Neothetics, IncCompletedSubcutaneous Abdominal AdiposityUnited States
-
University Hospital, BrestCompleted
-
University of SharjahAl Jalila FoundationCompleted
-
University Hospital, Basel, SwitzerlandRigshospitalet, DenmarkCompletedAdipositySwitzerland
-
University of Colorado, DenverNational Institute on Aging (NIA)Not yet recruitingMenopause | Aging | Adiposity | Estrogen DeficiencyUnited States
-
Pennington Biomedical Research CenterLouisiana Clinical and Translational Science CenterTerminatedAdiposity | Menopause Surgical | Estrogen DeficiencyUnited States
-
University of Southern CaliforniaTerminatedAdiposity | Obesity, AbdominalUnited States
-
University of California, San DiegoCompletedAdiposityUnited States
Clinical Trials on Vitamin D3 (cholecalciferol), 2000 IU per day
-
University of California, San FranciscoCompleted
-
Rutgers UniversityCompleted
-
The Hospital for Sick ChildrenUnity Health Toronto; Mount Sinai Hospital, CanadaCompletedRespiratory Tract Infections | Avitaminosis | AsthmaCanada
-
Andrea BranchUnknownHepatocellular Carcinoma | Vitamin D DeficiencyUnited States
-
Nationwide Children's HospitalOhio State UniversityUnknownVitamin D Deficiency | AsthmaUnited States
-
King Faisal Specialist Hospital & Research CenterTerminatedDiabetes Mellitus | Vitamin D DeficiencySaudi Arabia
-
Brigham and Women's HospitalNational Center for Maternal and Child Health Research, Mongolia; Zuun Kharaa...CompletedVitamin D Deficiency | PregnancyMongolia
-
Johns Hopkins UniversityNational Institute on Aging (NIA)TerminatedVitamin D Deficiency | FallsUnited States
-
Louis-Nicolas Veilleux Ph.D.CompletedOsteogenesis ImperfectaCanada
-
Augusta UniversityCompletedObesity | Overweight | Vitamin D DeficiencyUnited States