Baseline characteristics of participants in the VITamin D and OmegA-3 TriaL (VITAL)
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
Contemporary clinical trials · 88 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Sin resultado de salud
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Cancer Institute
- Gobierno
- National Institute of Arthritis and Musculoskeletal and Skin Diseases
- Gobierno
- NIAMS NIH HHS
- Sin clasificar
- U01
- Gobierno
- NCI NIH HHS
- Gobierno
- R01
- Subvenciones
- National Cancer Institute (U01CA138962); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR059086); National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR059775); National Cancer Institute (R01CA138962)
Según 6 financiadores declarados.
Publicación
- Publicado
- 2016-01-06 · Contemp Clin Trials · vol. 47 · págs. 235–243
- Editorial
- Elsevier BV
- Citado
- 101 citas · más que el 99% de estudios similares · 13.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 45 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
- VITAL trial, vitamin D supplementation, omega-3 fatty acids, fish oil, eicosapentaenoic acid, docosahexaenoic acid, vitamin D3, cancer prevention, cardiovascular disease prevention, primary prevention, baseline characteristics, African Americans, older adults
- MeSH
- humans, neoplasms, cardiovascular diseases, cholecalciferol, docosahexaenoic acids, eicosapentaenoic acid, vitamins, drug combinations, clinical protocols, double-blind method, primary prevention, research design, patient selection, dietary supplements, aged, aged, 80 and over, middle aged, female, male
14 autores
- Shari S. Bassuk🇺🇸 · autor de correspondenciaBrigham and Women's Hospital; Harvard University
- JoAnn E. Manson🇺🇸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
- William G. Christen🇺🇸Brigham and Women's Hospital; Harvard University
- Vadim Y. Bubes🇺🇸Brigham and Women's Hospital; Harvard University
- David Gordon🇺🇸Brigham and Women's Hospital; Harvard University
- Trisha Copeland🇺🇸Brigham and Women's Hospital; Harvard University
- Georgina Friedenberg🇺🇸Brigham and Women's Hospital; Harvard University
- Denise D’Agostino🇺🇸Brigham and Women's Hospital; Harvard University
- Claire Ridge🇺🇸Brigham and Women's Hospital; Harvard University
- Jean G. MacFadyen🇺🇸Brigham and Women's Hospital; Harvard University
- Kate Kalan🇺🇸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.
Evidence for a role of supplemental vitamin D and marine omega-3 fatty acids in preventing cancer and cardiovascular disease (CVD) remains inconclusive and insufficient to inform nutritional recommendations for primary prevention. The VITamin D and Omega-A 3 TriaL (VITAL) is an ongoing nationwide, randomized, double-blind, placebo-controlled clinical trial designed to fill this knowledge gap. The study population consists of 25,874 U.S. adults without cancer or CVD at baseline, who were selected only on age (men aged ≥50 and women aged ≥55), with an oversampling of African Americans (n=5,107). In a 2 × 2 factorial design, participants were randomized to one of four supplement groups: [1] active vitamin D3 (cholecalciferol; 2000 IU/d) and active marine omega-3 fatty acids (Omacor® fish oil, eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA], 1g/d); [2] active vitamin D and omega-3 placebo; [3] vitamin D placebo and active marine omega-3 fatty acids; or [4] vitamin D placebo and omega-3 placebo. The mean length of the randomized treatment period will be 5 years. The randomization was successful, as evidenced by similar distributions of baseline demographic, health, and behavioral characteristics across treatment groups. The similar distribution of known potential confounders across treatment groups strongly suggests that unmeasured or unknown potential confounders are also equally distributed. VITAL is expected to provide important information on the benefit-risk balance of vitamin D and omega-3 fatty acid supplementation when taken for the primary prevention of cancer and CVD.
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