Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study
Prentice RL, Pettinger MB, Jackson RD, Wactawski-Wende J, Lacroix AZ, Anderson GL, Chlebowski RT, Manson JE, Van Horn L, Vitolins MZ, Datta M, LeBlanc ES, Cauley JA, Rossouw JE
Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 200 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
- U.S. Department of Health and Human Services
- Universidad u hospital
- Brigham and Women's Hospital
- Universidad u hospital
- Ohio State University
- Universidad u hospital
- Wake Forest University
- Universidad u hospital
- University of Pittsburgh
- Universidad u hospital
- MedStar Health Research Institute
- Gobierno
- National Institutes of Health
- Gobierno
- U.S. Public Health Service
- Universidad u hospital
- University at Buffalo
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- National Cancer Institute
- Gobierno
- PHS HHS
- Gobierno
- WHI NIH HHS
- Gobierno
- NCI NIH HHS
- Subvenciones
- U.S. Department of Health and Human Services (42129‐32); U.S. Department of Health and Human Services (42107-26); U.S. Public Health Service (32101); National Institutes of Health (N01-WH-4-2107); National Institutes of Health (N01-WH-4-2122); U.S. Department of Health and Human Services (32108‐9); National Heart, Lung, and Blood Institute (32100‐2); National Cancer Institute (R01CA119171); U.S. Department of Health and Human Services (32118-32119); National Institutes of Health (N01-WH-3-2109); National Heart, Lung, and Blood Institute (32118‐32119); U.S. Department of Health and Human Services (32115); National Institutes of Health (N01-WH-3-2111); National Institutes of Health (N01-WH-3-2119); National Heart, Lung, and Blood Institute (N01‐WH‐22110); National Heart, Lung, and Blood Institute (N01WH22110, 24152, 32100-2, 32105-6, 32108-9, 32111-13, 32115, 32118-32119, 32122, 42107-26, 42129-32); National Heart, Lung, and Blood Institute (32118); National Institutes of Health (32122); U.S. Department of Health and Human Services (32111‐13); National Institutes of Health (32111‐13); National Institutes of Health (N01-WH-4-2126); National Cancer Institute (R25-CA-122061); National Institutes of Health (32108‐9); National Institutes of Health (42129‐32); National Institutes of Health (N01-WH-4-2111); U.S. Public Health Service (32100); National Institutes of Health (N01-WH-4-2129); National Institutes of Health (N01-WH-4-2130); National Institutes of Health (N01-WH-3-2118); National Institutes of Health (42107–26); National Heart, Lung, and Blood Institute (42107‐26); National Institutes of Health (N01-WH-4-2116); National Institutes of Health (N01-WH-4-2110); National Institutes of Health (N01 WH 44221); National Heart, Lung, and Blood Institute (32119); National Heart, Lung, and Blood Institute (24152); National Heart, Lung, and Blood Institute (and 44221); National Heart, Lung, and Blood Institute (32105–6); National Institutes of Health (N01-WH-3-2115); U.S. Department of Health and Human Services (32100‐2); National Institutes of Health (N01-WH-4-2117); National Institutes of Health (32118-32119); U.S. Public Health Service (24152); National Institutes of Health (44221); National Institutes of Health (32115); National Institutes of Health (32100‐2); National Heart, Lung, and Blood Institute (32108‐9); National Institutes of Health (N01-WH-4-2124); National Cancer Institute (P01-CA-053996); National Heart, Lung, and Blood Institute (32111–13); National Heart, Lung, and Blood Institute (32115); National Institutes of Health (N01-WH-4-2131); U.S. Department of Health and Human Services (44221); National Institutes of Health (N01-WH-4-2113); National Institutes of Health (N01-WH-4-2109); National Institutes of Health (N01-WH-4-2115); National Heart, Lung, and Blood Institute (42129‐32); National Institutes of Health (N01-WH-4-2132); U.S. Department of Health and Human Services (32105‐6); National Institutes of Health (N01-WH-3-2112); National Institutes of Health (N01-WH-4-2121); National Institutes of Health (N01-WH-4-2119); National Cancer Institute (CA53996); U.S. Department of Health and Human Services (32122); U.S. Department of Health and Human Services (24152); National Institutes of Health (N01-WH-3-2122); U.S. Department of Health and Human Services (N01-WH-2-2110); National Heart, Lung, and Blood Institute (32122); National Institutes of Health (N01-WH-4-2125); National Institutes of Health (N01-WH-4-2120); National Institutes of Health (N01-WH-2-2110); National Institutes of Health (N01-WH-4-2114); National Institutes of Health (N01-WH-4-2123); U.S. Public Health Service (32105); U.S. Public Health Service (32102); National Institutes of Health (N01-WH-4-2118); National Institutes of Health (24152); National Institutes of Health (N01-WH-4-2112); U.S. Public Health Service (32108); National Institutes of Health (N01-WH-4-2108); National Heart, Lung, and Blood Institute (44221); National Institutes of Health (N01 WH022110); National Institutes of Health (CA53996); National Institutes of Health (N01-WH-3-2113); National Institutes of Health (32105-6)
Según 14 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2012-12-03 · Osteoporos Int · vol. 24 · número 2 · págs. 567–580
- Editorial
- Springer Science+Business Media
- Citado
- 295 citas · más que el 100% de estudios similares · 20.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 31 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Vitamin D Research Studies · Bone health and osteoporosis research · Menopause: Health Impacts and Treatments
- Palabras clave
- calcium supplementation, vitamin D supplementation, postmenopausal women, hip fracture, fracture risk, cardiovascular disease, colorectal cancer, breast cancer, all-cause mortality, urolithiasis, duration of supplementation, Women's Health Initiative
- MeSH
- humans, neoplasms, osteoporosis, postmenopausal, urinary calculi, cardiovascular diseases, hip fractures, calcium carbonate, cholecalciferol, drug therapy, combination, drug administration schedule, risk assessment, double-blind method, dietary supplements, aged, middle aged, united states, female, bone density conservation agents, osteoporotic fractures
14 autores
- Ross L. Prentice🇺🇸 · autor de correspondenciaFred Hutch Cancer Center
- Mary B. Pettinger🇺🇸Fred Hutch Cancer Center
- Rebecca D. Jackson🇺🇸The Ohio State University
- Jean Wactawski‐Wende🇺🇸University at Buffalo, State University of New York
- Andrea Z. LaCroix🇺🇸Fred Hutch Cancer Center
- Garnet L. Anderson🇺🇸Fred Hutch Cancer Center
- Rowan T. Chlebowski🇺🇸The Lundquist Institute; Harbor–UCLA Medical Center
- JoAnn E. Manson🇺🇸Brigham and Women's Hospital; Harvard University
- Linda Van Horn🇺🇸Northwestern University
- Mara Z. Vitolins🇺🇸Wake Forest University Health Sciences; Wake Forest University
- Mridul Datta🇺🇸Wake Forest University Health Sciences; Wake Forest University
- Erin S. LeBlanc🇺🇸Kaiser Permanente Center for Health Research
- Jane A. Cauley🇺🇸University of Pittsburgh
- Jacques E. Rossouw🇺🇸National Institutes of Health; National Heart, Lung, and Blood Institute
Resumen
El texto original del estudio, en el idioma en que se publicó.
Summary
The Women's Health Initiative (WHI) double-blind, placebo-controlled clinical trial randomly assigned 36,282 postmenopausal women in the U.S. to 1,000 mg elemental calcium carbonate plus 400 IU of vitamin D(3) daily or placebo, with average intervention period of 7.0 years. The trial was designed to test whether calcium plus vitamin D supplementation in a population in which the use of these supplements was widespread would reduce hip fracture, and secondarily, total fracture and colorectal cancer.
Introduction
This study further examines the health benefits and risks of calcium and vitamin D supplementation using WHI data, with emphasis on fractures, cardiovascular disease, cancer, and total mortality.
Methods
WHI calcium and vitamin D randomized clinical trial (CT) data through the end of the intervention period were further analyzed with emphasis on treatment effects in relation to duration of supplementation, and these data were contrasted and combined with corresponding data from the WHI prospective observational study (OS).
Results
Among women not taking personal calcium or vitamin D supplements at baseline, the hazard ratio [HR] for hip fracture occurrence in the CT following 5 or more years of calcium and vitamin D supplementation versus placebo was 0.62 (95 % confidence interval (CI), 0.38-1.00). In combined analyses of CT and OS data, the corresponding HR was 0.65 (95 % CI, 0.44-0.98). Supplementation effects were not apparent on the risks of myocardial infarction, coronary heart disease, total heart disease, stroke, overall cardiovascular disease, colorectal cancer, or total mortality, while evidence for a reduction in breast cancer risk and total invasive cancer risk among calcium plus vitamin D users was only suggestive.
Conclusion
Though based primarily on a subset analysis, long-term use of calcium and vitamin D appears to confer a reduction that may be substantial in the risk of hip fracture among postmenopausal women. Other health benefits and risks of supplementation at doses considered, including an elevation in urinary tract stone formation, appear to be modest and approximately balanced.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY-NC).
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