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
Manson JE, Bassuk SS, Lee IM, Cook NR, Albert MA, Gordon D, Zaharris E, Macfadyen JG, Danielson E, Lin J, Zhang SM, Buring JE
Contemporary clinical trials · 400 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Institute on Aging
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- National Institute of Mental Health
- Gobierno
- National Cancer Institute
- Gobierno
- National Institute of Diabetes and Digestive and Kidney Diseases
- Gobierno
- National Center for Complementary and Alternative Medicine
- Gobierno
- National Institute of Neurological Disorders and Stroke
- Gobierno
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- Gobierno
- NIA NIH HHS
- Gobierno
- NIDDK NIH HHS
- Gobierno
- NIAMS NIH HHS
- Gobierno
- NIMH NIH HHS
- Gobierno
- NHLBI NIH HHS
- Gobierno
- NCI NIH HHS
- Subvenciones
- National Institute on Aging (R01AG036755); National Cancer Institute (U01CA138962); National Institute of Mental Health (R01MH091448); National Institute of Diabetes and Digestive and Kidney Diseases (R01DK088762); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01 AR060574); National Institute of Diabetes and Digestive and Kidney Diseases (R01DK088078); National Heart, Lung, and Blood Institute (R01 HL101932); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR059086); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR059775); National Heart, Lung, and Blood Institute (R01HL102122)
Según 14 financiadores declarados.
Publicación
- Publicado
- 2011-10-03 · Contemp Clin Trials · vol. 33 · número 1 · págs. 159–171
- Editorial
- Elsevier BV
- Citado
- 557 citas · más que el 100% de estudios similares · 30.0× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 125 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Vitamin D Research Studies · Fatty Acid Research and Health · Nutritional Studies and Diet
- Palabras clave
- vitamin D, marine omega-3 fatty acids, fish oil supplementation, eicosapentaenoic acid, docosahexaenoic acid, vitamin D3, primary prevention, cancer prevention, cardiovascular disease prevention, factorial trial, older adults, plasma biomarkers, medication adherence, ancillary studies, diabetes mellitus, hypertension, cognitive decline, osteoporosis, autoimmune disease
- MeSH
- humans, neoplasms, cardiovascular diseases, fatty acids, omega-3, fish oils, vitamins, vitamin d, treatment outcome, retrospective studies, follow-up studies, double-blind method, primary prevention, dietary supplements, middle aged, female, male
12 autores
- JoAnn E. Manson🇺🇸 · autor de correspondenciaBrigham and Women's Hospital; Harvard University
- Shari S. Bassuk🇺🇸Brigham and Women's Hospital; Harvard University
- I‐Min Lee🇺🇸Brigham and Women's Hospital; Harvard University
- Nancy R. Cook🇺🇸Brigham and Women's Hospital; Harvard University
- Michelle Asha Albert🇺🇸Brigham and Women's Hospital; Harvard University
- David Gordon🇺🇸Brigham and Women's Hospital; Harvard University
- Elaine Zaharris🇺🇸Brigham and Women's Hospital; Harvard University
- Jean G. MacFadyen🇺🇸Brigham and Women's Hospital; Harvard University
- Eleanor Danielson🇺🇸Brigham and Women's Hospital; Harvard University
- Jennifer Lin🇺🇸Brigham and Women's Hospital; Harvard University
- Shumin M. Zhang🇺🇸Brigham and Women's Hospital; Harvard University
- Julie E. Buring🇺🇸Brigham and Women's Hospital; Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Data from laboratory studies, observational research, and/or secondary prevention trials suggest that vitamin D and marine omega-3 fatty acids may reduce risk for cancer or cardiovascular disease (CVD), but primary prevention trials with adequate dosing in general populations (i.e., unselected for disease risk) are lacking. The ongoing VITamin D and OmegA-3 TriaL (VITAL) is a large randomized, double-blind, placebo-controlled, 2 x 2 factorial trial of vitamin D (in the form of vitamin D(3) [cholecalciferol], 2000 IU/day) and marine omega-3 fatty acid (Omacor fish oil, eicosapentaenoic acid [EPA]+docosahexaenoic acid [DHA], 1g/day) supplements in the primary prevention of cancer and CVD among a multi-ethnic population of 20,000 U.S. men aged ≥ 50 and women aged ≥ 55. The mean treatment period will be 5 years. Baseline blood samples will be collected in at least 16,000 participants, with follow-up blood collection in about 6000 participants. Yearly follow-up questionnaires will assess treatment compliance (plasma biomarker measures will also assess compliance in a random sample of participants), use of non-study drugs or supplements, occurrence of endpoints, and cancer and vascular risk factors. Self-reported endpoints will be confirmed by medical record review by physicians blinded to treatment assignment, and deaths will be ascertained through national registries and other sources. Ancillary studies will investigate whether these agents affect risk for diabetes and glucose intolerance; hypertension; cognitive decline; depression; osteoporosis and fracture; physical disability and falls; asthma and other respiratory diseases; infections; and rheumatoid arthritis, systemic lupus erythematosus, thyroid diseases, and other autoimmune disorders.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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