Skip to main content
OpenTrials
Completed

NCT Number: NCT02713009

Impact of Maternal Body Weight on Vitamin D Status During Pregnancy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Western Health and Social Care Trust, Altnagelvin

Londonderry, Co.Londonderry, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregnancy multi-vitamin (including 10μg vitamin D3)

Dietary Supplement

10μg vitamin D3

Dietary Supplement

0μg vitamin D (placebo)

Dietary Supplement

Primary outcomes

  1. Change in Vitamin D (25-hydroxyvitamin D) status

    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)

Secondary outcomes

  1. Gestational weight gain

    Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation)

  2. Change in inflammation status

    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)

  3. Change in bone turnover markers

    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)

  4. Genetics

    Time frame: Baseline (Week 12 gestation)

    e.g. CYP2R1, CYP27B1, CYP24A1

  5. Dietary intake

    Time frame: Week 28 gestation

    Food diary with food frequency questionnaire

  6. Foetal growth chart measurement

    Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

  7. Change in Vitamin D related measures

    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)

  8. Haemoglobin

    Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

    As part of full blood count

  9. Plasma ferritin

    Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

    Clinical chemistry analyser

  10. Transferrin saturation

    Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

    Clinical chemistry analyser

  11. Iron status

    Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

    Serum, clinical chemistry analyser

  12. Soluble transferrin receptor

    Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

    ELISA

  13. Hepcidion

    Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

    ELISA

  14. Methylation analysis

    Time frame: Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

    Iron and vitamin D related genes

Sponsors and collaborators

Lead sponsor

University of Ulster

Other

Collaborators

  • Western Health and Social Care Trust

Registry information

Official study title

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

Acronym: MO-VITD

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2016
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.