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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; et al. 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 (2016) Maternal gestational vitamin D supplementation and offspring bone health (MAVIDOS): a multicentre, double-blind, randomised placebo-controlled trial. Lancet Diabetes Endocrinol, 4 (5). pp. 393-402. ISSN 2213-8595 https://doi.org/10.1016/S2213-8587(16)00044-9
SGUL Authors: Papageorghiou, Aris

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Abstract

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.

Item Type: Article
Additional Information: © Cooper et al. Open Access article distributed under the terms of CC BY.
Keywords: MAVIDOS Study Group
SGUL Research Institute / Research Centre: Academic Structure > Institute of Medical & Biomedical Education (IMBE)
Academic Structure > Institute of Medical & Biomedical Education (IMBE) > Centre for Clinical Education (INMECE )
Journal or Publication Title: Lancet Diabetes Endocrinol
ISSN: 2213-8595
Language: eng
Dates:
DateEvent
1 May 2016Published
2 March 2016Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
MC_U105960371Medical Research CouncilUNSPECIFIED
MC_U147585819Medical Research CouncilUNSPECIFIED
MC_UP_A620_1014Medical Research CouncilUNSPECIFIED
MC_UU_12011/1Medical Research CouncilUNSPECIFIED
PubMed ID: 26944421
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/107856
Publisher's version: https://doi.org/10.1016/S2213-8587(16)00044-9

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