Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
25871 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-07-31
Study Completion Date
2026-05-31
Brief Summary
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The 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.
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Detailed Description
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The VITamin D and OmegA-3 TriaL (VITAL) is a randomized clinical trial of vitamin D (in the form of vitamin D3 \[cholecalciferol\]) and marine omega-3 fatty acid (eicosapentaenoic acid \[EPA\] + docosahexaenoic acid \[DHA\]) supplements in the primary prevention of cancer and cardiovascular disease (CVD). Existing data from laboratory studies, epidemiologic research, small primary prevention trials, and/or large secondary prevention trials strongly suggest that these nutritional agents may reduce risk for cancer or CVD, but large primary prevention trials with adequate dosing in general populations are lacking.
VITAL tested the independent effects of vitamin D and omega-3 fatty acid supplementation on risk for developing cancer and CVD (primary, secondary, and other outcomes are specified in the Outcome Measures section). VITAL also explored (a) whether vitamin D and omega-3 fatty acid supplements exhibit synergistic or additive effects on cancer and CVD risk and (b) whether the effect of each supplement on cancer and CVD risk varies by baseline blood levels or intake of vitamin D and EPA+DHA, race/ethnicity, and body mass index (for vitamin D), as well as age, sex, sunlight exposure, calcium intake, and baseline risk factors for cancer and CVD.
Eligible participants were assigned by chance (like a coin toss) to one of four groups: (1) daily vitamin D and omega-3; (2) daily vitamin D and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. Participants had an equal chance of being assigned to any of these four groups and a 3 out of 4 chance of getting at least one active agent.
Participants in all groups took two pills each day -- one softgel that contained either vitamin D or vitamin D placebo and one capsule that contained either omega-3 or omega-3 placebo. Participants received their study pills in convenient calendar packages via U.S. mail.
Participants fill out a short (15-20 minute) questionnaire each year. The questionnaire asks about health; lifestyle habits such as physical exercise, diet, and smoking; use of medications and dietary supplements; family history of illness, and new medical diagnoses. We request consent for medical record review to confirm endpoints. Occasionally, participants may receive a phone call from study staff to collect information or to clarify responses on the questionnaire.
At baseline, 16,954 VITAL participants provided an optional blood sample. Approximately 6,000 of these participants provided a follow-up blood sample during years 1-5 of the trial.
At baseline, year 2, and year 4 of the trial, a subcohort of 1,054 VITAL participants living within driving distance of Boston, Massachusetts received detailed in-clinic health assessments at the Clinical and Translational Science Center (CTSC) of Brigham and Women's Hospital. During CTSC visits, participants had a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provided fasting blood and urine samples, and underwent 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.
VITAL is supported by funding from the National Cancer Institute, National Heart, Lung and Blood Institute, Office of Dietary Supplements, National Institute of Neurological Disorders and Stroke, and the National Center for Complementary and Integrative Health. Pharmavite LLC of Northridge, California (vitamin D) and Pronova BioPharma (BASF) of Norway (Omacor® fish oil) donated the study agents, matching placebos, and packaging in the form of calendar packs.
VITAL tested the independent effects of vitamin D and omega-3 fatty acid supplementation on risk for developing cancer and CVD (primary, secondary, and other outcomes are specified in the Outcome Measures section). VITAL also explored (a) whether vitamin D and omega-3 fatty acid supplements exhibit synergistic or additive effects on cancer and CVD risk and (b) whether the effect of each supplement on cancer and CVD risk varies by baseline blood levels or intake of vitamin D and EPA+DHA, race/ethnicity, and body mass index (for vitamin D), as well as age, sex, sunlight exposure, calcium intake, and baseline risk factors for cancer and CVD.
Eligible participants were assigned by chance (like a coin toss) to one of four groups: (1) daily vitamin D and omega-3; (2) daily vitamin D and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. Participants had an equal chance of being assigned to any of these four groups and a 3 out of 4 chance of getting at least one active agent.
Participants in all groups took two pills each day -- one softgel that contained either vitamin D or vitamin D placebo and one capsule that contained either omega-3 or omega-3 placebo. Participants received their study pills in convenient calendar packages via U.S. mail.
Participants fill out a short (15-20 minute) questionnaire each year. The questionnaire asks about health; lifestyle habits such as physical exercise, diet, and smoking; use of medications and dietary supplements; family history of illness, and new medical diagnoses. We request consent for medical record review to confirm endpoints. Occasionally, participants may receive a phone call from study staff to collect information or to clarify responses on the questionnaire.
At baseline, 16,954 VITAL participants provided an optional blood sample. Approximately 6,000 of these participants provided a follow-up blood sample during years 1-5 of the trial.
At baseline, year 2, and year 4 of the trial, a subcohort of 1,054 VITAL participants living within driving distance of Boston, Massachusetts received detailed in-clinic health assessments at the Clinical and Translational Science Center (CTSC) of Brigham and Women's Hospital. During CTSC visits, participants had a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provided fasting blood and urine samples, and underwent 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.
VITAL is supported by funding from the National Cancer Institute, National Heart, Lung and Blood Institute, Office of Dietary Supplements, National Institute of Neurological Disorders and Stroke, and the National Center for Complementary and Integrative Health. Pharmavite LLC of Northridge, California (vitamin D) and Pronova BioPharma (BASF) of Norway (Omacor® fish oil) donated the study agents, matching placebos, and packaging in the form of calendar packs.
Conditions
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Cancer
Cardiovascular Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
PREVENTION
Blinding Strategy
TRIPLE
Participants
Investigators
Outcome Assessors
Study Groups
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Vitamin D + fish oil
Group Type
ACTIVE_COMPARATOR
vitamin D3
Intervention Type
DIETARY_SUPPLEMENT
Vitamin D3 (cholecalciferol), 2000 IU per day.
omega-3 fatty acids (fish oil)
Intervention Type
DRUG
Omacor, one 1-gram capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Vitamin D + fish oil placebo
Group Type
ACTIVE_COMPARATOR
vitamin D3
Intervention Type
DIETARY_SUPPLEMENT
Vitamin D3 (cholecalciferol), 2000 IU per day.
Fish oil placebo
Intervention Type
DIETARY_SUPPLEMENT
Fish oil placebo
Vitamin D placebo + fish oil
Group Type
ACTIVE_COMPARATOR
omega-3 fatty acids (fish oil)
Intervention Type
DRUG
Omacor, one 1-gram capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Vitamin D3 placebo
Intervention Type
DIETARY_SUPPLEMENT
Vitamin D placebo
Vitamin D placebo + fish oil placebo
Group Type
PLACEBO_COMPARATOR
Vitamin D3 placebo
Intervention Type
DIETARY_SUPPLEMENT
Vitamin D placebo
Fish oil placebo
Intervention Type
DIETARY_SUPPLEMENT
Fish oil placebo
Interventions
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vitamin D3
Vitamin D3 (cholecalciferol), 2000 IU per day.
Intervention Type
DIETARY_SUPPLEMENT
omega-3 fatty acids (fish oil)
Omacor, one 1-gram capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\]).
Intervention Type
DRUG
Vitamin D3 placebo
Vitamin D placebo
Intervention Type
DIETARY_SUPPLEMENT
Fish oil placebo
Fish oil placebo
Intervention Type
DIETARY_SUPPLEMENT
Other Intervention Names
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cholecalciferol
Eligibility Criteria
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Inclusion Criteria
1. be men aged 50 or older or women aged 55 or older;
2. have no history of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, coronary-artery bypass grafting, or percutaneous coronary intervention;
3. have none of the following safety exclusions: history of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or granulomatosis with polyangiitis (Wegener's);
4. have no allergy to fish or soy;
5. have no other serious illness that would preclude participation;
6. be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D \[e.g., Fosamax Plus D\], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
7. be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
8. not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
2. have no history of cancer (except non-melanoma skin cancer), heart attack, stroke, transient ischemic attack, angina pectoris, coronary-artery bypass grafting, or percutaneous coronary intervention;
3. have none of the following safety exclusions: history of renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or granulomatosis with polyangiitis (Wegener's);
4. have no allergy to fish or soy;
5. have no other serious illness that would preclude participation;
6. be consuming no more than 800 IU of vitamin D from all supplemental sources combined (individual vitamin D supplements, calcium+vitamin D supplements, medications with vitamin D \[e.g., Fosamax Plus D\], and multivitamins), or, if taking, willing to decrease or forego such use during the trial;
7. be consuming no more than 1200 mg/d of calcium from all supplemental sources combined, or, if taking, willing to decrease or forego such use during the trial;
8. not be taking fish oil supplements, or, if taking, willing to forego their use during the trial
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Sponsor Role
collaborator
Office of Dietary Supplements (ODS)
NIH
Sponsor Role
collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Sponsor Role
collaborator
National Center for Complementary and Integrative Health (NCCIH)
NIH
Sponsor Role
collaborator
Pharmavite LLC
INDUSTRY
Sponsor Role
collaborator
Pronova BioPharma
INDUSTRY
Sponsor Role
collaborator
BASF
INDUSTRY
Sponsor Role
collaborator
Brigham and Women's Hospital
OTHER
Sponsor Role
lead
Responsible Party
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JoAnn E. Manson, MD
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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JoAnn E. Manson, MD, DrPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Julie E. Buring, ScD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Site Status
Countries
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United States
References
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Bassuk SS, Manson JE, Lee IM, Cook NR, Christen WG, Bubes VY, Gordon DS, Copeland T, Friedenberg G, D'Agostino DM, Ridge CY, MacFadyen JG, Kalan K, Buring JE. Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL). Contemp Clin Trials. 2016 Mar;47:235-43. doi: 10.1016/j.cct.2015.12.022. Epub 2016 Jan 6.
Reference Type
BACKGROUND
Pradhan AD, Manson JE. Update on the Vitamin D and OmegA-3 trial (VITAL). J Steroid Biochem Mol Biol. 2016 Jan;155(Pt B):252-6. doi: 10.1016/j.jsbmb.2015.04.006. Epub 2015 Apr 9.
Reference Type
BACKGROUND
Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE. The VITamin D and OmegA-3 TriaL (VITAL): rationale and design of a large randomized controlled trial of vitamin D and marine omega-3 fatty acid supplements for the primary prevention of cancer and cardiovascular disease. Contemp Clin Trials. 2012 Jan;33(1):159-71. doi: 10.1016/j.cct.2011.09.009. Epub 2011 Oct 2.
Reference Type
BACKGROUND
Manson JE, Cook NR, Lee IM, Christen W, Bassuk SS, Mora S, Gibson H, Gordon D, Copeland T, D'Agostino D, Friedenberg G, Ridge C, Bubes V, Giovannucci EL, Willett WC, Buring JE; VITAL Research Group. Vitamin D Supplements and Prevention of Cancer and Cardiovascular Disease. N Engl J Med. 2019 Jan 3;380(1):33-44. doi: 10.1056/NEJMoa1809944. Epub 2018 Nov 10.
Reference Type
BACKGROUND
Manson JE, Cook NR, Lee IM, Christen W, Bassuk SS, Mora S, Gibson H, Albert CM, Gordon D, Copeland T, D'Agostino D, Friedenberg G, Ridge C, Bubes V, Giovannucci EL, Willett WC, Buring JE; VITAL Research Group. Marine n-3 Fatty Acids and Prevention of Cardiovascular Disease and Cancer. N Engl J Med. 2019 Jan 3;380(1):23-32. doi: 10.1056/NEJMoa1811403. Epub 2018 Nov 10.
Reference Type
BACKGROUND
Song M, Lee IM, Manson JE, Buring JE, Dushkes R, Gordon D, Walter J, Wu K, Chan AT, Ogino S, Fuchs CS, Meyerhardt JA, Giovannucci EL; VITAL Research Group. Effect of Supplementation With Marine omega-3 Fatty Acid on Risk of Colorectal Adenomas and Serrated Polyps in the US General Population: A Prespecified Ancillary Study of a Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):108-115. doi: 10.1001/jamaoncol.2019.4587.
Reference Type
BACKGROUND
Song M, Lee IM, Manson JE, Buring JE, Dushkes R, Gordon D, Walter J, Wu K, Chan AT, Ogino S, Fuchs CS, Meyerhardt JA, Giovannucci EL. No Association Between Vitamin D Supplementation and Risk of Colorectal Adenomas or Serrated Polyps in a Randomized Trial. Clin Gastroenterol Hepatol. 2021 Jan;19(1):128-135.e6. doi: 10.1016/j.cgh.2020.02.013. Epub 2020 Feb 13.
Reference Type
BACKGROUND
Hamaya R, Cook NR, Sesso HD, Buring JE, Manson JE. A Bayesian analysis of the VITAL trial: effects of omega-3 fatty acid supplementation on cardiovascular events. Am J Clin Nutr. 2025 May;121(5):1046-1053. doi: 10.1016/j.ajcnut.2025.02.028. Epub 2025 Mar 1.
Reference Type
DERIVED
Digvijaya, Mittal S, Mittal P, Singh R, Gupta S, Singh T, Khan R, Alzobaidi N, Alhalmi A. Vitamin D Fortification: A Promising Approach to Overcome Drug Resistance and Tolerance in Therapeutic Interventions. Scientifica (Cairo). 2024 Nov 22;2024:9978076. doi: 10.1155/2024/9978076. eCollection 2024.
Reference Type
DERIVED
Qian F, Guo Y, Li C, Liu Y, Luttmann-Gibson H, Gomelskaya N, Demler OV, Cook NR, Lee IM, Buring JE, Larsen J, Boring J, McPhaul MJ, Manson JE, Pradhan AD, Mora S. Biomarkers of glucose-insulin homeostasis and incident type 2 diabetes and cardiovascular disease: results from the Vitamin D and Omega-3 trial. Cardiovasc Diabetol. 2024 Nov 2;23(1):393. doi: 10.1186/s12933-024-02470-1.
Reference Type
DERIVED
Camargo CA Jr, Schaumberg DA, Friedenberg G, Dushkes R, Glynn RJ, Gold DR, Mora S, Lee IM, Buring JE, Manson JE. Effect of Daily Vitamin D Supplementation on Risk of Upper Respiratory Infection in Older Adults: A Randomized Controlled Trial. Clin Infect Dis. 2024 May 15;78(5):1162-1169. doi: 10.1093/cid/ciad770.
Reference Type
DERIVED
Vyas CM, Kang JH, Mischoulon D, Cook NR, Reynolds Iii CF, Chang G, Mora S, De Vivo I, Manson JE, Okereke OI. Apolipoprotein E and Its Association With Cognitive Change and Modification of Treatment Effects of Vitamin D3 and Omega-3s on Cognitive Change: Results From the In-Clinic Subset of a Randomized Clinical Trial. J Gerontol A Biol Sci Med Sci. 2024 Mar 1;79(3):glad260. doi: 10.1093/gerona/glad260.
Reference Type
DERIVED
Soens MA, Sesso HD, Manson JE, Fields KG, Buring JE, Lee IM, Cook NR, Kim E, Bubes V, Dushkes R, Serhan CN, Rathmell JP. The effect of vitamin D and omega-3 fatty acid supplementation on pain prevalence and severity in older adults: a large-scale ancillary study of the VITamin D and OmegA-3 triaL (VITAL). Pain. 2024 Mar 1;165(3):635-643. doi: 10.1097/j.pain.0000000000003044. Epub 2023 Oct 25.
Reference Type
DERIVED
Tikkanen JT, Soliman EZ, Pester J, Danik JS, Gomelskya N, Copeland T, Lee IM, Buring JE, Manson JE, Cook NR, Albert CM. A randomized clinical trial of omega-3 fatty acid and vitamin D supplementation on electrocardiographic risk profiles. Sci Rep. 2023 Jul 15;13(1):11454. doi: 10.1038/s41598-023-38344-x.
Reference Type
DERIVED
Vyas CM, Mischoulon D, Chang G, Reynolds CF 3rd, Cook NR, Weinberg A, Copeland T, Bubes V, Bradwin G, Lee IM, Buring JE, Mora S, Rifai N, Manson JE, Okereke OI. Relation of serum BDNF to major depression and exploration of mechanistic roles of serum BDNF in a study of vitamin D3 and omega-3 supplements for late-life depression prevention. J Psychiatr Res. 2023 Jul;163:357-364. doi: 10.1016/j.jpsychires.2023.05.069. Epub 2023 May 26.
Reference Type
DERIVED
Vyas CM, Sadreyev RI, Gatchel JR, Kang JH, Reynolds CF, Mischoulon D, Chang G, Hazra A, Manson JE, Blacker D, De Vivo I, Okereke OI. Pilot Study of Second-Generation DNA Methylation Epigenetic Markers in Relation to Cognitive and Neuropsychiatric Symptoms in Older Adults. J Alzheimers Dis. 2023;93(4):1563-1575. doi: 10.3233/JAD-230093.
Reference Type
DERIVED
Hlatky MA, Gonzalez PE, Manson JE, Buring JE, Lee IM, Cook NR, Mora S, Bubes V, Stone NJ. Statin-Associated Muscle Symptoms Among New Statin Users Randomly Assigned to Vitamin D or Placebo. JAMA Cardiol. 2023 Jan 1;8(1):74-80. doi: 10.1001/jamacardio.2022.4250.
Reference Type
DERIVED
Bassuk SS, Manson JE; VITAL Research Group. Marine omega-3 fatty acid supplementation and prevention of cardiovascular disease: update on the randomized trial evidence. Cardiovasc Res. 2023 Jun 13;119(6):1297-1309. doi: 10.1093/cvr/cvac172.
Reference Type
DERIVED
Chandra A, Picard MH, Huang S, Gupta DK, Agusala K, Buring JE, Lee IM, Cook NR, Manson JE, Thadhani RI, Wang TJ. Impact of Vitamin D3 Versus Placebo on Cardiac Structure and Function: A Randomized Clinical Trial. J Am Heart Assoc. 2022 Nov;11(21):e025008. doi: 10.1161/JAHA.121.025008. Epub 2022 Oct 26.
Reference Type
DERIVED
Orkaby AR, Dushkes R, Ward R, Djousse L, Buring JE, Lee IM, Cook NR, LeBoff MS, Okereke OI, Copeland T, Manson JE. Effect of Vitamin D3 and Omega-3 Fatty Acid Supplementation on Risk of Frailty: An Ancillary Study of a Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231206. doi: 10.1001/jamanetworkopen.2022.31206.
Reference Type
DERIVED
Djousse L, Cook NR, Kim E, Walter J, Al-Ramady OT, Luttmann-Gibson H, Albert CM, Mora S, Buring JE, Gaziano JM, Manson JE. Diabetes Mellitus, Race, and Effects of Omega-3 Fatty Acids on Incidence of Heart Failure Hospitalization. JACC Heart Fail. 2022 Apr;10(4):227-234. doi: 10.1016/j.jchf.2021.12.006. Epub 2022 Mar 9.
Reference Type
DERIVED
Hahn J, Cook NR, Alexander EK, Friedman S, Walter J, Bubes V, Kotler G, Lee IM, Manson JE, Costenbader KH. Vitamin D and marine omega 3 fatty acid supplementation and incident autoimmune disease: VITAL randomized controlled trial. BMJ. 2022 Jan 26;376:e066452. doi: 10.1136/bmj-2021-066452.
Reference Type
DERIVED
Okereke OI, Vyas CM, Mischoulon D, Chang G, Cook NR, Weinberg A, Bubes V, Copeland T, Friedenberg G, Lee IM, Buring JE, Reynolds CF 3rd, Manson JE. Effect of Long-term Supplementation With Marine Omega-3 Fatty Acids vs Placebo on Risk of Depression or Clinically Relevant Depressive Symptoms and on Change in Mood Scores: A Randomized Clinical Trial. JAMA. 2021 Dec 21;326(23):2385-2394. doi: 10.1001/jama.2021.21187.
Reference Type
DERIVED
Kang JH, Vyas CM, Okereke OI, Ogata S, Albert M, Lee IM, D'Agostino D, Buring JE, Cook NR, Grodstein F, Manson JE. Effect of vitamin D on cognitive decline: results from two ancillary studies of the VITAL randomized trial. Sci Rep. 2021 Dec 1;11(1):23253. doi: 10.1038/s41598-021-02485-8.
Reference Type
DERIVED
Markland AD, Vaughan C, Huang A, Kim E, Bubes VY, Tangpricha V, Buring J, Lee IM, Cook N, Manson JE, Grodstein F. Effect of vitamin D supplementation on urinary incontinence in older women: ancillary findings from a randomized trial. Am J Obstet Gynecol. 2022 Apr;226(4):535.e1-535.e12. doi: 10.1016/j.ajog.2021.10.017. Epub 2021 Oct 19.
Reference Type
DERIVED
Best CM, Zelnick LR, Thummel KE, Hsu S, Limonte C, Thadhani R, Sesso HD, Manson JE, Buring JE, Mora S, Lee IM, Cook NR, Friedenberg G, Luttmann-Gibson H, de Boer IH, Hoofnagle AN. Serum Vitamin D: Correlates of Baseline Concentration and Response to Supplementation in VITAL-DKD. J Clin Endocrinol Metab. 2022 Jan 18;107(2):525-537. doi: 10.1210/clinem/dgab693.
Reference Type
DERIVED
Bassuk SS, Chandler PD, Buring JE, Manson JE; VITAL Research Group. The VITamin D and OmegA-3 TriaL (VITAL): Do Results Differ by Sex or Race/Ethnicity? Am J Lifestyle Med. 2020 Dec 24;15(4):372-391. doi: 10.1177/1559827620972035. eCollection 2021 Jul-Aug.
Reference Type
DERIVED
Albert CM, Cook NR, Pester J, Moorthy MV, Ridge C, Danik JS, Gencer B, Siddiqi HK, Ng C, Gibson H, Mora S, Buring JE, Manson JE. Effect of Marine Omega-3 Fatty Acid and Vitamin D Supplementation on Incident Atrial Fibrillation: A Randomized Clinical Trial. JAMA. 2021 Mar 16;325(11):1061-1073. doi: 10.1001/jama.2021.1489.
Reference Type
DERIVED
Chou SH, Murata EM, Yu C, Danik J, Kotler G, Cook NR, Bubes V, Mora S, Chandler PD, Tobias DK, Copeland T, Buring JE, Manson JE, LeBoff MS. Effects of Vitamin D3 Supplementation on Body Composition in the VITamin D and OmegA-3 TriaL (VITAL). J Clin Endocrinol Metab. 2021 Apr 23;106(5):1377-1388. doi: 10.1210/clinem/dgaa981.
Reference Type
DERIVED
Chandler PD, Chen WY, Ajala ON, Hazra A, Cook N, Bubes V, Lee IM, Giovannucci EL, Willett W, Buring JE, Manson JE; VITAL Research Group. Effect of Vitamin D3 Supplements on Development of Advanced Cancer: A Secondary Analysis of the VITAL Randomized Clinical Trial. JAMA Netw Open. 2020 Nov 2;3(11):e2025850. doi: 10.1001/jamanetworkopen.2020.25850.
Reference Type
DERIVED
Okereke OI, Reynolds CF 3rd, Mischoulon D, Chang G, Vyas CM, Cook NR, Weinberg A, Bubes V, Copeland T, Friedenberg G, Lee IM, Buring JE, Manson JE. Effect of Long-term Vitamin D3 Supplementation vs Placebo on Risk of Depression or Clinically Relevant Depressive Symptoms and on Change in Mood Scores: A Randomized Clinical Trial. JAMA. 2020 Aug 4;324(5):471-480. doi: 10.1001/jama.2020.10224.
Reference Type
DERIVED
Farukhi ZM, Demler OV, Caulfield MP, Kulkarni K, Wohlgemuth J, Cobble M, Luttmann-Gibson H, Li C, Nelson JR, Cook NR, Buring JE, Krauss RM, Manson JE, Mora S. Comparison of nonfasting and fasting lipoprotein subfractions and size in 15,397 apparently healthy individuals: An analysis from the VITamin D and OmegA-3 TriaL. J Clin Lipidol. 2020 Mar-Apr;14(2):241-251. doi: 10.1016/j.jacl.2020.02.005. Epub 2020 Feb 21.
Reference Type
DERIVED
LeBoff MS, Chou SH, Murata EM, Donlon CM, Cook NR, Mora S, Lee IM, Kotler G, Bubes V, Buring JE, Manson JE. Effects of Supplemental Vitamin D on Bone Health Outcomes in Women and Men in the VITamin D and OmegA-3 TriaL (VITAL). J Bone Miner Res. 2020 May;35(5):883-893. doi: 10.1002/jbmr.3958. Epub 2020 Jan 30.
Reference Type
DERIVED
Manson JE, Bassuk SS, Cook NR, Lee IM, Mora S, Albert CM, Buring JE; VITAL Research Group. Vitamin D, Marine n-3 Fatty Acids, and Primary Prevention of Cardiovascular Disease Current Evidence. Circ Res. 2020 Jan 3;126(1):112-128. doi: 10.1161/CIRCRESAHA.119.314541. Epub 2020 Jan 2.
Reference Type
DERIVED
Manson JE, Bassuk SS, Buring JE; VITAL Research Group. Principal results of the VITamin D and OmegA-3 TriaL (VITAL) and updated meta-analyses of relevant vitamin D trials. J Steroid Biochem Mol Biol. 2020 Apr;198:105522. doi: 10.1016/j.jsbmb.2019.105522. Epub 2019 Nov 13.
Reference Type
DERIVED
Costenbader KH, MacFarlane LA, Lee IM, Buring JE, Mora S, Bubes V, Kotler G, Camargo CA Jr, Manson JE, Cook NR. Effects of One Year of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Biomarkers of Systemic Inflammation in Older US Adults. Clin Chem. 2019 Dec;65(12):1508-1521. doi: 10.1373/clinchem.2019.306902. Epub 2019 Nov 7.
Reference Type
DERIVED
Luttmann-Gibson H, Mora S, Camargo CA, Cook NR, Demler OV, Ghoshal A, Wohlgemuth J, Kulkarni K, Larsen J, Prentice J, Cobble M, Bubes V, Li C, Friedenberg G, Lee IM, Buring JE, Manson JE. Serum 25-hydroxyvitamin D in the VITamin D and OmegA-3 TriaL (VITAL): Clinical and demographic characteristics associated with baseline and change with randomized vitamin D treatment. Contemp Clin Trials. 2019 Dec;87:105854. doi: 10.1016/j.cct.2019.105854. Epub 2019 Oct 24.
Reference Type
DERIVED
Okereke OI, Reynolds CF 3rd, Mischoulon D, Chang G, Cook NR, Copeland T, Friedenberg G, Buring JE, Manson JE. The VITamin D and OmegA-3 TriaL-Depression Endpoint Prevention (VITAL-DEP): Rationale and design of a large-scale ancillary study evaluating vitamin D and marine omega-3 fatty acid supplements for prevention of late-life depression. Contemp Clin Trials. 2018 May;68:133-145. doi: 10.1016/j.cct.2018.02.017. Epub 2018 Mar 8.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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http://www.vitalstudy.org
VITAL study website
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