A Double-Blind Randomised Placebo-Controlled Trial of Vitamin D Supplements for Pregnant Women with Low Levels of Vitamin D in Early Pregnancy - MAVIDOS

Conditions

Osteoporosis MedDRA version: 9.1 Level: LLT Classification code 10005991 Term: Bone mass decreased

Moon RJ, D' Angelo S, Curtis EM, Ward KA, Crozier SR, Schoenmakers I, Javaid MK, Bishop NJ, Godfrey KM, Cooper C, Harvey NC, MAVIDOS Trial Group.

2024-09-196 citations

10.1016/j.ajcnut.2024.09.014

Bone turnover in pregnancy, measured by urinary CTX, is influenced by vitamin D supplementation and is associated with maternal bone health: findings from the Maternal Vitamin D Osteoporosis Study (MAVIDOS) trial

Elizabeth Curtis, Camille Parsons, Kate Maslin, Stefania D’Angelo, Rebecca J Moon et al. (20 authors)

American Journal of Clinical Nutrition2021-07-2025 citations

10.1093/ajcn/nqab264

The Effect of Vitamin D Supplementation on Hepcidin, Iron Status, and Inflammation in Pregnant Women in the United Kingdom

Vickie Braithwaite, Sarah Crozier, Stefania D’Angelo, Ann Prentice, Cyrus Cooper et al. (8 authors)

Nutrients2019-01-1838 citations

10.3390/nu11010190

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.

2016-03-02158 citations

10.1016/s2213-8587(16)00044-9

Interventions

Trade Name: Cholecalciferol Manufactured in USA by Pure Encapsulations and DHP Pharma will certify release in UK. Product Name: cholecalciferol Pharmaceutical Form: Capsule* Pharmaceutical form of th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pregnant women serum 25(OH)-vitamin D concentration is 25-100 nmol/l at 12 weeks gestation aged over 18 years Singleton pregnancy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Known metabolic bone disease Current medication likely to interfere with intrauterine growth (corticosteroids, anticonvulsants, PTH, bisphosphonates foetal physical anomalies on the 12 week scan inability to provide informed consent or comply with trial protocol. History of renal stones, hyperparathyroidism, hypercalcuria, Measured hypercalacemia (>2.75mmol/l) A diagnosis of cancer in the last 10 years Cod liver oil of vitamin supplements containing vitamin D

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the hypothesis that vitamin D supplementation during pregnancy of women who are have low levels of vitamin D will result in improved neonatal bone mineral content. ;Secondary Objective: To examine the effect of maternal vitamin D supplementation on neonatal anthropometry and body composition (weight, length and skinfold thickness measurements) To assess women’s attitude to pregnancy vitamin D supplementation (qualitative study) Cost-utility analysis Assessment of bone turnover markers during and after pregnancy, bone mineral accrual by aged 4 years, glucose handling in infancy;Primary end point(s): Whole body bone area, bone mineral content and bone mineral density measured by DXA within 10 days of birth in the offspring	—

Measure

Time frame

Main Objective: To test the hypothesis that vitamin D supplementation during pregnancy of women who are have low levels of vitamin D will result in improved neonatal bone mineral content. ;Secondary Objective: To examine the effect of maternal vitamin D supplementation on neonatal anthropometry and body composition (weight, length and skinfold thickness measurements) To assess women’s attitude to pregnancy vitamin D supplementation (qualitative study) Cost-utility analysis Assessment of bone turnover markers during and after pregnancy, bone mineral accrual by aged 4 years, glucose handling in infancy;Primary end point(s): Whole body bone area, bone mineral content and bone mineral density measured by DXA within 10 days of birth in the offspring

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Countries

United Kingdom

Outcome results

None listed