We are not investigating a medical condition as such, but the effect of vitamin D on offspring body composition and bone mass, which are risk factors for later ill health.
Conditions
Interventions
Trade Name: Vigantoletten 1000
Product Name: Vigantoletten 1000
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women will be eligible for the study if they: • attend the Princess Anne Hospital for nuchal lucency scans between 9 and 17 weeks gestation (based on LMP and dating scan); • are aged over 18 years; • have a singleton pregnancy; • are aiming to give birth at local maternity hospital. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 248 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Women will be excluded from the study if they: • have known metabolic bone disease or chronic disease known to be associated with bone disease; • are taking part in another research study; • are taking medication likely to interfere with intrauterine growth (corticosteroids, anticonvulsants, PTH, bisphosphonates, more than 6 months GnRH analogues); • show fetal physical anomalies on the 12 week scan (likely to influence bone mass on DXA or interfere with skeletal development); • are unable to provide informed consent or comply with the trial protocol; • have a history of renal stones, hyperparathyroidism, hypercalcaemia or known hypercalcuria; • have a diagnosis of cancer in the last 10 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve maternal vitamin D levels and body composition assessed by DXA at birth, in infants born to women who have been randomised to receive vitamin D supplements or placebo, and further randomised to receive behaviour change support in pregnancy by trained nurses or to receive usual care.;Secondary Objective: To collect data on interim outcomes for the women and infants, including breast feeding at two weeks, pregnancy weight gain, quality of diet and self-efficacy for feeding themselves and their children assessed at 14 weeks and 34 weeks of pregnancy, and to conduct a detailed process evaluation of the intervention and compliance, including recruitment and retention of participants, exploration of staff experiences of supporting women to change their health behaviour, and the costs and benefits for women of changing their health behaviour.;Primary end point(s): Vitamin D status in women.;Timepoint(s) of evaluation of this end point: Maternal 25(OH)-vitamin D levels will be assessed in blood samples taken during the 34th week of pregnancy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Body composition of infants Maternal weight gains in pregnancy Rates of breastfeeding initiation and duration Dietary quality of women Self-efficacy of women;Timepoint(s) of evaluation of this end point: Body composition of infants will be measure by DXA within 2 weeks of birth. Maternal weight will be tracked through pregnancy. Rates of breastfeeding will be assessed by questionnaire one month post-natally. Dietary quality and self-efficacy will be assessed at two time points during pregnancy and one month post-natally. | — |
Countries
United Kingdom
Contacts
Public ContactNicholas C W Harvey
MRC Lifecourse Epidemiology Unit
Outcome results
None listed