AdiposityVITALNCT01785004
Vitamin D and Omega-3 Adiposity Trial (VITAL Adiposity)
A study testing Vitamin D3 (cholecalciferol), 2000 IU per day and omega-3 fatty acids (fish oil) in people with Adiposity, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adiposity
- What is being tested?
- Vitamin D3 (cholecalciferol), 2000 IU per day and omega-3 fatty acids (fish oil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in VITAL (NCT 01169259) who are willing to participate in this ancillary study and undergo DXA evaluation (baseline and 2 years)
Who cannot join
- Inability to travel to the Clinical and Translational Science Center in Boston where imaging, anthropometric measurements, and blood work will be performed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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.
- Conditions
- Adiposity
- Being tested
- Vitamin D3 (cholecalciferol), 2000 IU per day, omega-3 fatty acids (fish oil)
- Keywords
- Adiposity, Body composition, Vitamin D, Adipokines, Omega-3 fatty acid
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 (cholecalciferol), 2000 IU per dayDietary supplement
cholecalciferol
omega-3 fatty acids (fish oil)Drug
Also called 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]).
| Study group | Role | What they receive |
|---|---|---|
| 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]) Receives: 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 Receives: 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]) Receives: Drug: omega-3 fatty acids (fish oil) |
| Vitamin D placebo + fish oil placebo | Placebo comparator | Vitamin D placebo and fish oil placebo Receives: Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day; Drug: omega-3 fatty acids (fish oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
Anthropometric Measurements
We will perform and compare changes in anthropometric measurements, including BMI, waist circumference and waist-hip ratio.
Measured: 2 years
Mediation of CVD risk factors by body composition
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.
Measured: 2 years
Adipokines
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.
Measured: 2 years
Achieved 25(OH)D level
We will assess whether achieved 25(OH)D levels with supplementation are affected by baseline and change in body composition and BMI.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2013 (estimated)
- Study startJul 2012
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Jacqueline Suk Danik, MD, DrPH, Brigham and Women's Hospital
- Investigators
- Jacqueline S. Danik, MD, DrPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785004
- Sponsor's protocol ID
- 2012P001304
- Other IDs
- 12GRNT11980009
- Acronym
- VITAL
- Status last verified
- Apr 2021
- First submitted
- 23 Jan 2013
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interrelationship of Vitamin D Supplementation, Adiposity and CVD Risk Factors in a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01785004
- Acronym / sponsor ID
- VITAL / 2012P001304
- Conditions
- Adiposity
- Keywords
- Adiposity, Body composition, Vitamin D, Adipokines, Omega-3 fatty acid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2012
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 6 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vitamin D + fish oil | Active comparator | Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day, Drug: omega-3 fatty acids (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]) |
| Vitamin D + fish oil placebo | Active comparator | Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per dayVitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo |
| Vitamin D placebo + fish oil | Active comparator | Drug: omega-3 fatty acids (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]) |
| Vitamin D placebo + fish oil placebo | Placebo comparator | Dietary Supplement: Vitamin D3 (cholecalciferol), 2000 IU per day, Drug: omega-3 fatty acids (fish oil)Vitamin D placebo and fish oil placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants in VITAL (NCT 01169259) who are willing to participate in this ancillary study and undergo DXA evaluation (baseline and 2 years)
Key exclusion criteria (1 listed)
- Inability to travel to the Clinical and Translational Science Center in Boston where imaging, anthropometric measurements, and blood work will be performed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 (cholecalciferol), 2000 IU per daycholecalciferol | Dietary supplement | Vitamin D + fish oil, Vitamin D + fish oil placebo, Vitamin D placebo + fish oil placebo |
| omega-3 fatty acids (fish oil)Also: 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]). | Drug | Vitamin D + fish oil, Vitamin D placebo + fish oil, Vitamin D placebo + fish oil placebo |
Primary outcome
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.
4 secondary outcomes
Anthropometric Measurements
Time frame: 2 years
Mediation of CVD risk factors by body composition
Time frame: 2 years
Adipokines
Time frame: 2 years
Achieved 25(OH)D level
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacqueline S. Danik, MD, DrPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 (cholecalciferol), 2000 IU per day and omega-3 fatty acids (fish oil) in people with Adiposity, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.