Financiado en parte por Amgen, Eli Lilly and Company, AstraZeneca, Alexion Pharmaceuticals, Danone, Alere, Bupa Foundation, Fonterra Co-Operative Group, Teijin Pharma, Nestec
Maternal gestational vitamin D supplementation and offspring bone health (MAVIDOS): a multicentre, double-blind, randomised placebo-controlled trial
Cooper C, Harvey NC, Bishop NJ, Kennedy S, Papageorghiou AT, Schoenmakers I, Fraser R, Gandhi SV, Carr A, D'Angelo S, Crozier SR, Moon RJ, Arden NK, Dennison EM, Godfrey KM, Inskip HM, Prentice A, Mughal MZ, Eastell R, Reid DM, Javaid MK, MAVIDOS Study Group
The lancet. Diabetes & endocrinology · 172 citas
Etiquetas de revisión
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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
- Amgen
- Empresa
- Eli Lilly and Company
- Empresa
- AstraZeneca
- Empresa
- Alexion Pharmaceuticals
- Empresa
- Danone
- Empresa
- Alere
- Universidad u hospital
- University Hospital Southampton NHS Foundation Trust
- Organización sin fines de lucro
- American Society for Bone and Mineral Research
- Gobierno
- National Institute for Health and Care Research
- Organización sin fines de lucro
- British Heart Foundation
- Organización sin fines de lucro
- National Osteoporosis Society
- Empresa
- Bupa Foundation
- Universidad u hospital
- University of Southampton
- Universidad u hospital
- University of Oxford
- Gobierno
- European Commission
- Empresa
- Fonterra Co-Operative Group
- Empresa
- Teijin Pharma
- Organización sin fines de lucro
- Versus Arthritis
- Empresa
- Nestec
- Gobierno
- Medical Research Council
- Organización sin fines de lucro
- Arthritis UK
- Gobierno
- European Union's Seventh Framework Programme
- Gobierno
- National Institute for Health Research (NIHR)
- Subvenciones
- Medical Research Council (FP7/20072013); National Institute for Health and Care Research (10/33/04); European Commission (613977); Medical Research Council (MR/K006312/1); National Institute for Health and Care Research (FP7/2007–2013); National Institute for Health and Care Research (HTA/10/33/04); Medical Research Council (Programme code U105960371); European Commission (2007–2013); National Institute for Health and Care Research (NF-SI-0515-10042); Medical Research Council (MC_UU_12011/4); European Commission (FP7 2007-2013); Medical Research Council (U105960371); National Institute for Health and Care Research (613977); British Heart Foundation (RG/07/009/23120); National Institute for Health and Care Research (NF-SI-0508-10082); National Institute for Health and Care Research (289346); European Commission (FP7/2007); Versus Arthritis (19583); Versus Arthritis (17702); Medical Research Council (MC_UU_12011/1); National Institute for Health and Care Research (NF-SI-0513-10085); National Institute for Health and Care Research (NF-SI-0513-10073); European Commission (289346)
Según 23 financiadores declarados.
Publicación
- Publicado
- 2016-03-02 · Lancet Diabetes Endocrinol · vol. 4 · número 5 · págs. 393–402
- Editorial
- Elsevier BV
- Citado
- 238 citas · más que el 100% de estudios similares · 28.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 42 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Vitamin D Research Studies · Bone health and osteoporosis research · Birth, Development, and Health
- Palabras clave
- maternal vitamin D supplementation, vitamin D3, pregnancy, 25-hydroxyvitamin D, vitamin D deficiency, osteoporosis prevention, prenatal supplementation
- MeSH
- humans, vitamin d, double-blind method, seasons, pregnancy, bone density, dietary supplements, adult, infant, newborn, female, bone density conservation agents, prenatal nutritional physiological phenomena
21 autores
- Cyrus C. Cooper🇬🇧 · autor de correspondenciaSouthampton General Hospital; University Hospital Southampton NHS Foundation Trust; University of Oxford; NIHR Oxford Biomedical Research Centre; NIHR Southampton Biomedical Research Centre; MRC Lifecourse Epidemiology Unit; University of Southampton
- Nicholas C. Harvey🇬🇧Southampton General Hospital; University Hospital Southampton NHS Foundation Trust; NIHR Southampton Biomedical Research Centre; MRC Lifecourse Epidemiology Unit; University of Southampton
- Nicholas J. Bishop🇬🇧Sheffield Children's Hospital; University of Sheffield
- Stephen Kennedy🇬🇧John Radcliffe Hospital; University of Oxford
- Aris T. Papageorghiou🇬🇧John Radcliffe Hospital; University of Oxford
- Inez Schoenmakers🇬🇧MRC Elsie Widdowson Laboratory
- Robert B. Fraser🇬🇧University of Sheffield
- Saurabh V. Gandhi🇬🇧University of Sheffield
- Andrew Jonathan Carr🇬🇧University of Oxford; NIHR Oxford Biomedical Research Centre
- Stefania D’Angelo🇬🇧Southampton General Hospital; MRC Lifecourse Epidemiology Unit; University of Southampton
- Sarah Crozier🇬🇧Southampton General Hospital; MRC Lifecourse Epidemiology Unit; University of Southampton
- Rebecca Jane Moon🇬🇧Southampton General Hospital; MRC Lifecourse Epidemiology Unit; University of Southampton
- Nigel Arden🇬🇧University of Oxford; NIHR Oxford Biomedical Research Centre
- Elaine Margaret Dennison🇬🇧Southampton General Hospital; MRC Lifecourse Epidemiology Unit; University of Southampton
- Keith M. Godfrey🇬🇧Southampton General Hospital; University Hospital Southampton NHS Foundation Trust; NIHR Southampton Biomedical Research Centre; MRC Lifecourse Epidemiology Unit; University of Southampton
- Hazel M. Inskip🇬🇧Southampton General Hospital; MRC Lifecourse Epidemiology Unit; University of Southampton
- Ann Prentice🇬🇧MRC Elsie Widdowson Laboratory
- Zulf Mughal🇬🇧Royal Manchester Children's Hospital
- Richard Eastell🇬🇧University of Sheffield
- David M. Reid🇬🇧University of Aberdeen
- M K Javaid🇬🇧University of Oxford; NIHR Oxford Biomedical Research Centre
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Maternal vitamin D status has been associated with bone mass of offspring in many, but not all, observational studies. However, maternal vitamin D repletion during pregnancy has not yet been proven to improve offspring bone mass in a randomised controlled trial. We aimed to assess whether neonates born to mothers supplemented with vitamin D during pregnancy have greater whole-body bone mineral content (BMC) at birth than those of mothers who had not received supplementation.
Methods
The Maternal Vitamin D Osteoporosis Study (MAVIDOS) was a multicentre, double-blind, randomised, placebo-controlled trial that recruited pregnant women from three study sites in the UK (Southampton, Oxford, and Sheffield). Eligible participants were older than 18 years, with a singleton pregnancy, gestation of less than 17 weeks, and a serum 25-hydroxyvitamin D (25[OH]D) concentration of 25-100 nmol/L at 10-17 weeks' gestation. P'articipants were randomly assigned (1:1), in randomly permuted blocks of ten, to either cholecalciferol 1000 IU/day or matched placebo, taken orally, from 14 weeks' gestation (or as soon as possible before 17 weeks' gestation if recruited later) until delivery. Participants and the research team were masked to treatment allocation. The primary outcome was neonatal whole-body BMC, assessed within 2 weeks of birth by dual-energy x-ray absorptiometry (DXA), analysed in all randomly assigned neonates who had a usable DXA scan. Safety outcomes were assessed in all randomly assigned participants. This trial is registered with the International Standard Randomised Controlled Trial registry, ISRCTN 82927713, and the European Clinical Trials Database, EudraCT 2007-001716-23.
Findings
Between Oct 10, 2008, and Feb 11, 2014, we randomly assigned 569 pregnant women to placebo and 565 to cholecalciferol 1000 IU/day. 370 (65%) neonates in the placebo group and 367 (65%) neonates in the cholecalciferol group had a usable DXA scan and were analysed for the primary endpoint. Neonatal whole-body BMC of infants born to mothers assigned to cholecalciferol 1000 IU/day did not significantly differ from that of infants born to mothers assigned to placebo (61·6 g [95% CI 60·3-62·8] vs 60·5 g [59·3-61·7], respectively; p=0·21). We noted no significant differences in safety outcomes, apart from a greater proportion of women in the placebo group with severe post-partum haemorrhage than those in the cholecalciferol group (96 [17%] of 569 mothers in the placebo group vs 65 [12%] of 565 mothers in the cholecalciferol group; p=0·01). No adverse events were deemed to be treatment related.
Interpretation
Supplementation of women with cholecalciferol 1000 IU/day during pregnancy did not lead to increased offspring whole-body BMC compared with placebo, but did show that 1000 IU of cholecalciferol daily is sufficient to ensure that most pregnant women are vitamin D replete, and it is safe. These findings support current approaches to vitamin D supplementation in pregnancy. Results of the ongoing MAVIDOS childhood follow-up study are awaited.
Funding
Arthritis Research UK, Medical Research Council, Bupa Foundation, and National Institute for Health Research.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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