Vitamin D and Omega-3 Trial (VITAL)

NCT01169259 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 3 other identifiers: 2009P-001217U01CA138962R01CA138962
• Study Type: interventional
• Target: 25,871
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer; Cardiovascular Disease

Keywords

vitamin D3; omega-3 fatty acids; fish oil; cardiovascular disease; cancer; primary prevention

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Invasive Cancer of Any Type

  Number of participants with invasive cancer of any type

  5 years

• Number of Participants With a Major Cardiovascular Event

  Major cardiovascular event = a composite endpoint of myocardial infarction, stroke, and death from cardiovascular causes

  5 years

Secondary Outcomes (11)

• Number of Participants Who Died From Invasive Cancer of Any Type

  5 years

• Number of Female Participants With Breast Cancer

  5 years

• Number of Male Participants With Prostate Cancer

  5 years

• Number of Participants With Colorectal Cancer

  5 years

• Number of Participants With Cardiovascular Event in Expanded Composite Cardiovascular Endpoint

  5 years

Other Outcomes (13)

• Number of Participants Who Died From Invasive Cancer of Any Type, Excluding First 2 Years of Follow-up

  5 years, excluding first 2 years of follow-up

• Number of Participants Who Died From Any Cause, Excluding First 2 Years of Follow-up

  5 years, excluding first 2 years of follow-up

• Number of Participants With Percutaneous Coronary Intervention

  5 years

Study Arms (4)

Vitamin D + fish oil

ACTIVE COMPARATOR

Dietary Supplement: vitamin D3; Drug: omega-3 fatty acids (fish oil)

Vitamin D + fish oil placebo

ACTIVE COMPARATOR

Dietary Supplement: vitamin D3; Dietary Supplement: Fish oil placebo

Vitamin D placebo + fish oil

ACTIVE COMPARATOR

Drug: omega-3 fatty acids (fish oil); Dietary Supplement: Vitamin D3 placebo

Vitamin D placebo + fish oil placebo

PLACEBO COMPARATOR

Dietary Supplement: Vitamin D3 placebo; Dietary Supplement: Fish oil placebo

Interventions

vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 (cholecalciferol), 2000 IU per day.

Also known as: cholecalciferol

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

omega-3 fatty acids (fish oil) 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; Vitamin D placebo + fish oil

Vitamin D3 placebo DIETARY_SUPPLEMENT

Vitamin D placebo

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

Fish oil placebo DIETARY_SUPPLEMENT

Fish oil placebo

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

Eligibility Criteria

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

To be eligible for the study, respondents had to, at study entry,: 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Cancer Institute (NCI): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Office of Dietary Supplements (ODS): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Pharmavite LLC: collaborator
• Pronova BioPharma: collaborator
• BASF: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (38)

• 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.

  PMID: 26767629 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.

  PMID: 25864623 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.

  PMID: 21986389 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.

  PMID: 30415629 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.

  PMID: 30415637 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.

  PMID: 31750855 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.

  PMID: 32062040 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.

  PMID: 40032221 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.

  PMID: 39618688 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.

  PMID: 39488682 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.

  PMID: 38113446 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.

  PMID: 37952113 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.

  PMID: 37878483 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.

  PMID: 37454148 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.

  PMID: 37267732 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.

  PMID: 37212116 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.

  PMID: 36416841 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.

  PMID: 36378553 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.

  PMID: 36285795 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.

  PMID: 36098968 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.

  PMID: 35361440 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.

  PMID: 35082139 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.

  PMID: 34932079 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.

  PMID: 34853363 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.

  PMID: 34678177 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.

  PMID: 34543425 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.

  PMID: 34366734 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.

  PMID: 33724323 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.

  PMID: 33513226 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.

  PMID: 33206192 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.

  PMID: 32749491 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.

  PMID: 32205068 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.

  PMID: 31923341 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.

  PMID: 31895658 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.

  PMID: 31733345 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.

  PMID: 31699704 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.

  PMID: 31669447 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.

  PMID: 29526608 DERIVED

Related Links

• VITAL study website

MeSH Terms

Conditions

Neoplasms; Cardiovascular Diseases

Interventions

Cholecalciferol; Fatty Acids, Omega-3; Fish Oils

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

Results Point of Contact

• Title: VITAL Study Director
• Organization: Brigham and Women's Hospital; 900 Commonwealth Ave, 3rd fl.; Boston, MA 02215

vitalstudy@partners.org

1-800-388-3963

Study Officials

• JoAnn E. Manson, MD, DrPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Julie E. Buring, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, 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 13, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2010
• Primary Completion: November 10, 2018
• Study Completion: May 1, 2026
• Last Updated: November 6, 2025
• Results First Posted: January 6, 2020

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)