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MAVIDOS maternal vitamin D osteoporosis study: study protocol for a randomized controlled trial. The MAVIDOS Study Group

MAVIDOS maternal vitamin D osteoporosis study: study protocol for a randomized controlled trial. The MAVIDOS Study Group
MAVIDOS maternal vitamin D osteoporosis study: study protocol for a randomized controlled trial. The MAVIDOS Study Group
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
1745-6215
p.13
Harvey, N.C.
ce487fb4-d360-4aac-9d17-9466d6cba145
Javaid, M.K.
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Bishop, N.
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Kennedy, S.
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Papageorghiou, A.T.
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Fraser, R.
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Gandhi, S.V.
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Schoenmakers, I.
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Prentice, A.
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Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Harvey, N.C.
ce487fb4-d360-4aac-9d17-9466d6cba145
Javaid, M.K.
51d3310b-032e-4c15-83ac-b878bce090f3
Bishop, N.
3d9fae1a-1a35-4a75-807e-f01cbc93012d
Kennedy, S.
d78526a0-8c23-4c94-b25a-c0fa85025f5c
Papageorghiou, A.T.
f99d2e42-8146-4ff2-804a-e68193fef668
Fraser, R.
1d2e1003-e025-4cb6-b411-5687fa2f5e0f
Gandhi, S.V.
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Schoenmakers, I.
64ce38c3-a9df-4426-b01d-dc0ec968038b
Prentice, A.
b103f864-7606-4860-8bf2-125b4be3c0f3
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6

Harvey, N.C., Javaid, M.K., Bishop, N., Kennedy, S., Papageorghiou, A.T., Fraser, R., Gandhi, S.V., Schoenmakers, I., Prentice, A. and Cooper, C. (2012) MAVIDOS maternal vitamin D osteoporosis study: study protocol for a randomized controlled trial. The MAVIDOS Study Group. Trials, 13 (1), p.13. (doi:10.1186/1745-6215-13-13). (PMID:22314083)

Record type: Article

Abstract

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

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Published date: February 2012
Organisations: Faculty of Health Sciences

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Local EPrints ID: 336414
URI: http://eprints.soton.ac.uk/id/eprint/336414
ISSN: 1745-6215
PURE UUID: 311d0806-242a-4736-80f2-fb8c16fa8d51
ORCID for N.C. Harvey: ORCID iD orcid.org/0000-0002-8194-2512
ORCID for C. Cooper: ORCID iD orcid.org/0000-0003-3510-0709

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Date deposited: 28 Mar 2012 15:13
Last modified: 18 Mar 2024 02:58

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Contributors

Author: N.C. Harvey ORCID iD
Author: M.K. Javaid
Author: N. Bishop
Author: S. Kennedy
Author: A.T. Papageorghiou
Author: R. Fraser
Author: S.V. Gandhi
Author: I. Schoenmakers
Author: A. Prentice
Author: C. Cooper ORCID iD

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