Impact of Maternal Body Weight on Vitamin D Status During Pregnancy

Obesity Clinical Trial

— MO-VITD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713009
• Other study ID #: REC 15/NI/0068
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: March 2018

Study information

• Verified date: February 2023
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Pregnancy multi-vitamin (including 10µg vitamin D3)

• 10µg vitamin D3

• 0µg vitamin D (placebo)

Locations

Country	Name	City	State
United Kingdom	Western Health and Social Care Trust, Altnagelvin	Londonderry	Co.Londonderry

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	Western Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gestational weight gain		Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation)
Secondary	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)
Secondary	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)
Secondary	Genetics	e.g. CYP2R1, CYP27B1, CYP24A1	Baseline (Week 12 gestation)
Secondary	Dietary intake	Food diary with food frequency questionnaire	Week 28 gestation
Secondary	Foetal growth chart measurement		Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Secondary	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)
Secondary	Haemoglobin	As part of full blood count	Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Secondary	Plasma ferritin	Clinical chemistry analyser	Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Secondary	Transferrin saturation	Clinical chemistry analyser	Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Secondary	Iron status	Serum, clinical chemistry analyser	Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Secondary	Soluble transferrin receptor	ELISA	Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Secondary	Hepcidion	ELISA	Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Secondary	Methylation analysis	Iron and vitamin D related genes	Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)