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: 9.1Level: LLTClassification code 10005991Term: Bone mass decreased

Registration Number: EUCTR2007-001716-23-GB

Lead Sponsor: Southampton University Hospitals NHS Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 1000

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>To assess women’s attitude to pregnancy vitamin D supplementation (qualitative study)<br>Cost-utility analysis<br>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

Secondary Outcome Measures