Maternal vItamin D osteoporosis study

Conditions

Osteoporosis Musculoskeletal Diseases Osteoporosis without pathological fracture

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

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

The relationship between maternal self-efficacy, compliance and outcome in a trial of vitamin D supplementation in pregnancy.

Barker M, D'Angelo S, Ntani G, Lawrence W, Baird J, Jarman M, Vogel C, Inskip H, Cooper C, Harvey NC, MAVIDOS Study Group.

2016-08-2210 citations

10.1007/s00198-016-3721-5

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.

2012-02-0753 citations

10.1186/1745-6215-13-13

Interventions

This trial comprises pilot and main studies: Pilot study for the first 18 months, three groups of 60 participants each (total number of participants = 180): Group 1: 400 iu vitamin D3 (oral) per da

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Less than 19 weeks gestation at first assessment (based on last menstrual period [LMP] and dating scan) 2. Serum 25(OH)-vitamin D concentration is 25-100 nmol/l at nuchal fold/ dating scan (10 to 19 weeks gestation) 3. Aged over 18 years 4. Singleton pregnancy 5. Aiming to give birth at local hospital

Exclusion criteria

Exclusion criteria: 1. Known metabolic bone disease 2. Current medication likely to interfere with intrauterine growth (corticosteroids, anticonvulsants, parathyroid hormone [PTH], bisphosphonates) 3. Foetal physical anomalies on the 12 week scan 4. Inability to provide informed consent or comply with trial protocol 5. History of renal stones, hyperparathyroidism, hypercalcuria 6. Measured hypercalacemia (>2.75 mmol/l) 7. A diagnosis of cancer in the last 10 years 8. Cod liver oil of vitamin supplements containing vitamin D >200 iu per day 9. In-vitro fertilisation treatment

Design outcomes

Primary

Measure	Time frame
Neonatal whole body bone area, bone mineral content and bone mineral density assessed by dual energy x-ray absorptiometry (DXA) within 10 days of birth.	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 14/06/2023: 1. Neonatal and childhood anthropometry and body composition (weight, length and skinfold thickness measurements), assessed within 48 hours of birth 2. Women's attitude to pregnancy vitamin D supplementation (qualitative study; assessed in main study only). Methodology and timepoints of assessment not yet defined as of 03/03/2008 3. Childhood bone mass at 4 years 4. Childhood bone mass, bone microarchitecture and grip strength at age 6-7 years 5. Offspring anthropometry and musculoskeletal health measured using a DXA scan, High-resolution peripheral quantitative computed tomography (HR-pQCT), grip strength, jumping mechanography and biochemical parameters (including metabolomics, 25(OH)D, bone turnover markers) at age 11-14 years Previous secondary outcome measures: 1. Neonatal and childhood anthropometry and body composition (weight, length and skinfold thickness measurements), assessed within 48 hours of birth 2. Women's attitude to pregnancy vitamin D supplementation (qualitative study; assessed in main study only). Methodology and timepoints of assessment not yet defined as of 03/03/2008 3. Childhood bone mass at 4 years	—

Measure

Time frame

Current secondary outcome measures as of 14/06/2023: 1. Neonatal and childhood anthropometry and body composition (weight, length and skinfold thickness measurements), assessed within 48 hours of birth 2. Women's attitude to pregnancy vitamin D supplementation (qualitative study; assessed in main study only). Methodology and timepoints of assessment not yet defined as of 03/03/2008 3. Childhood bone mass at 4 years 4. Childhood bone mass, bone microarchitecture and grip strength at age 6-7 years 5. Offspring anthropometry and musculoskeletal health measured using a DXA scan, High-resolution peripheral quantitative computed tomography (HR-pQCT), grip strength, jumping mechanography and biochemical parameters (including metabolomics, 25(OH)D, bone turnover markers) at age 11-14 years Previous secondary outcome measures: 1. Neonatal and childhood anthropometry and body composition (weight, length and skinfold thickness measurements), assessed within 48 hours of birth 2. Women's attitude to pregnancy vitamin D supplementation (qualitative study; assessed in main study only). Methodology and timepoints of assessment not yet defined as of 03/03/2008 3. Childhood bone mass at 4 years

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Countries

England, United Kingdom

Outcome results

None listed