Impact of Maternal Body Weight on Vitamin D Status During Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of the Impact of Maternal Body Weight on Vitamin D Status During Pregnancy: a Randomised Supplementation Study

Conditions
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Obesity, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3)
* Dietary Supplement: 10μg vitamin D3
* Dietary Supplement: 0μg vitamin D (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women Age ≥18years BMI >18.5 kg/m² Without current pregnancy related complications At least 12 weeks gestation Have a singleton pregnancy (as confirmed at first scan) Pregnant women who are currently taking vitamin D and have had a sun holiday will be included in this study. All participants will agree to discontinue any current supplementation and will be provided with a multivitamin for the duration of pregnancy. Exclusion Criteria: Aged <18 years Pregnancy BMI <18.5kg/m² Participants with multiple pregnancy Participants currently involved in another research study Participants with a history of gastrointestinal, hepatic, renal, vascular or haematological disorders. Participants who have had in vitro fertilisation (IVF) treatment Participants with a history of NTD affected pregnancies Pregnant women with active thyroid disease (e.g., Graves, Hashimoto or thyroiditis) Planned home births

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>Pregnancy multivitamin + vitamin D daily from  Week 12 gestation until delivery | Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3)<br> <br> Dietary Supplement: 10μg vitamin D3<br> <br> |
| Placebo Comparator: Treatment 2<br>Pregnancy multivitamin + placebo daily from  Week 12 gestation until delivery | Dietary Supplement: Pregnancy multi-vitamin (including 10μg vitamin D3)<br> <br> Dietary Supplement: 0μg vitamin D (placebo)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vitamin D (25-hydroxyvitamin D) status | Serum Vitamin D status (Week 12, 28 + 36 gestation) & cord serum Vitamin D status (delivery) | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational weight gain |  | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation) | 
| Change in inflammation status | Plasma inflammation status (Week 12, 28 + 36 gestation) & cord plasma inflammation status (delivery) | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Change in bone turnover markers | Plasma bone turnover markers (Week 12, 28 + 36 gestation) & cord plasma bone turnover markers (delivery) | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Genetics | e.g. CYP2R1, CYP27B1, CYP24A1 | Baseline (Week 12 gestation) | 
| Dietary intake | Food diary with food frequency questionnaire | Week 28 gestation | 
| Foetal growth chart measurement |  | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Change in Vitamin D related measures | Blood Vitamin D related status (Week 12, 28 + 36 gestation) & cord Vitamin D related status (delivery) | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Haemoglobin | As part of full blood count | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Plasma ferritin | Clinical chemistry analyser | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Transferrin saturation | Clinical chemistry analyser | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Iron status | Serum, clinical chemistry analyser | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Soluble transferrin receptor | ELISA | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Hepcidion | ELISA | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 
| Methylation analysis | Iron and vitamin D related genes | Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal body weight, Vitamin D, Pregnancy