Type(s) of Cancer
All,Breast,Colorectal,Prostate
All,Breast,Colorectal,Prostate
Study Phase
Phase 3
Study Completion Date
November 2018
November 2018
NCT01169259Uploaded 03-19-2021
Available for Download
PDS UID: Multiple_Brigham_454
Vitamin D and Omega-3 Trial (VITAL)
Provider Information
Provider Data DescriptionThe VITamin D and OmegA-3 TriaL (VITAL) was a randomized factorial clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) ended on December 31, 2017.
The primary aims were:
1. To test whether vitamin D3 supplementation reduces the risk of (a) total cancer (excluding non-melanoma skin cancer) and (b) major CVD events (a composite endpoint of myocardial infarction [MI], stroke, and cardiovascular mortality).
2. To test whether EPA+DHA supplementation reduces the risk of (a) total cancer (excluding non-melanoma skin cancer) and (b) major CVD events.
Secondary aims were:
1. To test whether vitamin D3 or EPA+DHA supplementation reduces the risk of (a) incident colorectal cancer, (b) incident breast cancer (in women), (c) incident prostate cancer (in men), and (d) total cancer mortality.
2. To test whether vitamin D3 or EPA+DHA supplementation reduces the risk of (a) an expanded composite cardiovascular endpoint of MI, stroke, cardiovascular mortality, and coronary revascularization (i.e., coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]) and (b) the individual components of the primary cardiovascular endpoint, particularly total CVD mortality.
SponsorBrigham and Women's Hospital
Data ProviderBrigham and Women's Hospital
Partial set or SubsetComposite
Patients in dataset25871
# of Patients Control25871
# of Patients Experimental25871
DOIN/A
CDISC StandardNot CDISC
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThe VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The 5-year intervention phase (study pill-taking, median 5.3 years) has ended; post-intervention observational follow-up of study participants is ongoing.
ConditionsCancer
Cardiovascular Disease
Cardiovascular Disease
Intervention TypeDietary Supplement: vitamin D3
Drug: omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3 placebo
Dietary Supplement: Fish oil placebo
Drug: omega-3 fatty acids (fish oil)
Dietary Supplement: Vitamin D3 placebo
Dietary Supplement: Fish oil placebo
Drug(s)Drug: omega-3 fatty acids (fish oil)
Total Enrolled25871
RandomizationRandomized
Blinding MethodTriple
Arms InterventionVitamin D + fish oil - Active Comparator
Vitamin D + fish oil placebo - Active Comparator
Vitamin D placebo + fish oil - Active Comparator
Vitamin D placebo + fish oil placebo - Placebo Comparator
Vitamin D + fish oil placebo - Active Comparator
Vitamin D placebo + fish oil - Active Comparator
Vitamin D placebo + fish oil placebo - Placebo Comparator
Secondary IDU01CA138962
PubMed (PMID)26767629
25864623
21986389
30415629
30415637
31750855
32062040
33724323
33206192
32749491
32205068
31923341
31895658
31733345
31699704
31669447
29526608
25864623
21986389
30415629
30415637
31750855
32062040
33724323
33206192
32749491
32205068
31923341
31895658
31733345
31699704
31669447
29526608
Collaborator(s)National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Pharmavite LLC
Pronova BioPharma
BASF
National Heart, Lung, and Blood Institute (NHLBI)
Office of Dietary Supplements (ODS)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
Pharmavite LLC
Pronova BioPharma
BASF
Region(s)United States
Age RangeMinimum Age: 50 Years
Maximum Age: N/A
Maximum Age: N/A
Files:
PROTOCOLManson_VITAL_protocol_NEJM_2019.pdf
CRFManson_VITAL_crf_placeholder.docx
Data DictionaryVITAL_data_dictionary_11-17-20.docx
DATA SUMMARYVITAL_trial_NEJM_2019_dataprofile.xlsx
DATA SUMMARYProc Contents Data Dictionary VITAL_trial_NEJM_2019.pdf
DATA (COMPARATOR ARM)vital_data_2019.sas7bdat
