Financiado en parte por F. Hoffmann-La Roche
Vitamin D supplementation during pregnancy: double-blind, randomized clinical trial of safety and effectiveness
Hollis BW, Johnson D, Hulsey TC, Ebeling M, Wagner CL
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 536 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiado por la industria
- Empresa
- F. Hoffmann-La Roche
- Gobierno
- National Center for Research Resources
- Gobierno
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Gobierno
- NCRR NIH HHS
- Gobierno
- NICHD NIH HHS
- Subvenciones
- National Center for Research Resources (#UL1RR029882); Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD047511); National Center for Research Resources (RR-01070); Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD47511); National Center for Research Resources (M01 RR001070); Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD043921)
Según 5 financiadores declarados.
Publicación
- Publicado
- 2011-06-27 · J Bone Miner Res · vol. 26 · número 10 · págs. 2341–2357
- Editorial
- Oxford University Press
- Citado
- 846 citas · más que el 100% de estudios similares · 45.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 106 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Vitamin D Research Studies · Vitamin K Research Studies · Nutrition and Health Studies
- Palabras clave
- vitamin D supplementation, pregnancy, vitamin D3, 25-hydroxyvitamin D, 1,25-dihydroxyvitamin D3, vitamin D sufficiency, dose comparison, maternal safety, neonatal outcomes, calcium supplementation, vitamin D deficiency, vitamin D toxicity
- MeSH
- humans, vitamin d, double-blind method, pregnancy, dietary supplements, female
5 autores
- Bruce W. Hollis🇺🇸 · autor de correspondenciaMedical University of South Carolina
- Donna Johnson🇺🇸Medical University of South Carolina
- Thomas C. Hulsey🇺🇸Medical University of South Carolina
- Myla D. Ebeling🇺🇸Medical University of South Carolina
- Carol L. Wagner🇺🇸Medical University of South Carolina
Resumen
El texto original del estudio, en el idioma en que se publicó.
The need, safety, and effectiveness of vitamin D supplementation during pregnancy remain controversial. In this randomized, controlled trial, women with a singleton pregnancy at 12 to 16 weeks' gestation received 400, 2000, or 4000 IU of vitamin D(3) per day until delivery. The primary outcome was maternal/neonatal circulating 25-hydroxyvitamin D [25(OH)D] concentration at delivery, with secondary outcomes of a 25(OH)D concentration of 80 nmol/L or greater achieved and the 25(OH)D concentration required to achieve maximal 1,25-dihydroxyvitamin D(3) [1,25(OH)(2)D(3)] production. Of the 494 women enrolled, 350 women continued until delivery: Mean 25(OH)D concentrations by group at delivery and 1 month before delivery were significantly different (p < 0.0001), and the percent who achieved sufficiency was significantly different by group, greatest in 4000-IU group (p < 0.0001). The relative risk (RR) for achieving a concentration of 80 nmol/L or greater within 1 month of delivery was significantly different between the 2000- and the 400-IU groups (RR = 1.52, 95% CI 1.24-1.86), the 4000- and the 400-IU groups (RR = 1.60, 95% CI 1.32-1.95) but not between the 4000- and. 2000-IU groups (RR = 1.06, 95% CI 0.93-1.19). Circulating 25(OH)D had a direct influence on circulating 1,25(OH)(2)D(3) concentrations throughout pregnancy (p < 0.0001), with maximal production of 1,25(OH)(2)D(3) in all strata in the 4000-IU group. There were no differences between groups on any safety measure. Not a single adverse event was attributed to vitamin D supplementation or circulating 25(OH)D levels. It is concluded that vitamin D supplementation of 4000 IU/d for pregnant women is safe and most effective in achieving sufficiency in all women and their neonates regardless of race, whereas the current estimated average requirement is comparatively ineffective at achieving adequate circulating 25(OH)D concentrations, especially in African Americans.
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