Western Health and Social Care Trust, Altnagelvin
Londonderry, Co.Londonderry, United Kingdom
NCT Number: NCT02713009
Research shows high levels of vitamin D deficiency in pregnant women in Northern Ireland. Body composition is a determinant of vitamin D status. Vitamin D is a fat soluble vitamin and therefore may be hidden within the adipose/fat tissue in overweight/obese individuals. All pregnant and breastfeeding women are advised to take a daily supplement containing 10μg vitamin D. The investigators hypothesise that overweight/ obese pregnant women have a lower vitamin D status than their leaner counterparts at the start of pregnancy and may need a higher daily supplementation to achieve a sufficient status.
The investigators propose a randomised supplementation study where pregnant women (n 240) from the Western Health and Social Care Trust Area will be invited to take part.
Inclusion criteria: pregnant women first trimester, without current pregnancy related complications, singleton pregnancy, aged ≥18 years, with Body Mass Index (BMI) > 18.5kg /m².
Participants will be randomised to receive either 0μg (placebo) plus a multivitamin or 10μg vitamin D plus a multivitamin from 12 weeks gestation until delivery. The multivitamin already contains 10μg vitamin D; Therefore participants will be randomised to receive a total of 10μg or 20μg vitamin D.
Blood samples (20mls) will be taken at 12, 28 and 36 weeks gestation. A sample of blood will be taken from the cord after delivery. Vitamin D status is the main outcome measurement. All blood samples will be analysed for vitamin D and other associated metabolites. Data will be collected on health and lifestyle, supplementation use and food intake. Body composition measurements will be recorded at each appointment and infant anthropometric measurements will be taken from the maternal notes after delivery. Findings from this research will be used to inform nutrition policy on appropriate vitamin D supplementation levels in pregnancy which may be dependent upon pre pregnancy BMI.
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Notify Me18 year and older
Female
Interventional
Not applicable
Londonderry, Co.Londonderry, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Serum Vitamin D status (Week 12, 28 + 36 gestation) & cord serum Vitamin D status (delivery)
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation)
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Plasma inflammation status (Week 12, 28 + 36 gestation) & cord plasma inflammation status (delivery)
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Plasma bone turnover markers (Week 12, 28 + 36 gestation) & cord plasma bone turnover markers (delivery)
Time frame: Baseline (Week 12 gestation)
e.g. CYP2R1, CYP27B1, CYP24A1
Time frame: Week 28 gestation
Food diary with food frequency questionnaire
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Blood Vitamin D related status (Week 12, 28 + 36 gestation) & cord Vitamin D related status (delivery)
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
As part of full blood count
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Clinical chemistry analyser
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Clinical chemistry analyser
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Serum, clinical chemistry analyser
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
ELISA
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
ELISA
Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Iron and vitamin D related genes
University of Ulster
Other
Investigation of the Impact of Maternal Body Weight on Vitamin D Status During Pregnancy: a Randomised Supplementation Study
Acronym: MO-VITD
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