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MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group.

Harvey, NC; Javaid, K; Bishop, N; Kennedy, S; Papageorghiou, AT; Fraser, R; Gandhi, SV; Schoenmakers, I; Prentice, A; Cooper, C (2012) MAVIDOS Maternal Vitamin D Osteoporosis Study: study protocol for a randomized controlled trial. The MAVIDOS Study Group. TRIALS, 13 (13). ISSN 1745-6215 https://doi.org/10.1186/1745-6215-13-13
SGUL Authors: Papageorghiou, Aris

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Abstract

MAVIDOS is a randomised, double-blind, placebo-controlled trial (ISRCTN82927713, registered 2008 Apr 11), funded by Arthritis Research UK, MRC, Bupa Foundation and NIHR. Background: Osteoporosis is a major public health problem as a result of associated fragility fractures. Skeletal strength increases from birth to a peak in early adulthood. This peak predicts osteoporosis risk in later life. Vitamin D insufficiency in pregnancy is common (31% in a recent Southampton cohort) and predicts reduced bone mass in the offspring. In this study we aim to test whether offspring of mothers supplemented with vitamin D in pregnancy have higher bone mass at birth than those whose mothers were not supplemented. Methods/Design: Women have their vitamin D status assessed after ultrasound scanning in the twelfth week of pregnancy at 3 trial centres (Southampton, Sheffield, Oxford). Women with circulating 25(OH)-vitamin D levels 25- 100 nmol/l are randomised in a double-blind design to either oral vitamin D supplement (1000 IU cholecalciferol/ day, n = 477) or placebo at 14 weeks (n = 477). Questionnaire data include parity, sunlight exposure, dietary information, and cigarette and alcohol consumption. At 19 and 34 weeks maternal anthropometry is assessed and blood samples taken to measure 25(OH)-vitamin D, PTH and biochemistry. At delivery venous umbilical cord blood is collected, together with umbilical cord and placental tissue. The babies undergo DXA assessment of bone mass within the first 14 days after birth, with the primary outcome being whole body bone mineral content adjusted for gestational age and age. Children are then followed up with yearly assessment of health, diet, physical activity and anthropometric measures, with repeat assessment of bone mass by DXA at age 4 years. Discussion: As far as we are aware, this randomised trial is one of the first ever tests of the early life origins hypothesis in human participants and has the potential to inform public health policy regarding vitamin D supplementation in pregnancy. It will also provide a valuable resource in which to study the influence of maternal vitamin D status on other childhood outcomes such as glucose tolerance, blood pressure, cardiovascular function, IQ and immunology.

Item Type: Article
Additional Information: © 2012 Harvey et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: Absorptiometry, Photon, Administration, Oral, Age Factors, Biological Markers, Bone Density, Bone and Bones, Child, Preschool, Cholecalciferol, Dietary Supplements, Double-Blind Method, England, Female, Gestational Age, Humans, Infant, Infant, Newborn, Osteoporosis, Pregnancy, Pregnancy Complications, Research Design, Treatment Outcome, Vitamin D, Vitamin D Deficiency
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: TRIALS
ISSN: 1745-6215
Dates:
DateEvent
7 February 2012Published
PubMed ID: 22314083
Web of Science ID: 22314083
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URI: https://openaccess.sgul.ac.uk/id/eprint/100242
Publisher's version: https://doi.org/10.1186/1745-6215-13-13

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