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Impact of Maternal Body Weight on Vitamin D Status During Pregnancy (MO-VITD)

Primary Purpose

Obesity, Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Pregnancy multi-vitamin (including 10μg vitamin D3)
10μg vitamin D3
0μg vitamin D (placebo)
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Maternal body weight, Vitamin D, Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Western Health and Social Care Trust, Altnagelvin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment 1

Treatment 2

Arm Description

Pregnancy multivitamin + vitamin D daily from ~Week 12 gestation until delivery

Pregnancy multivitamin + placebo daily from ~Week 12 gestation until delivery

Outcomes

Primary Outcome Measures

Change in Vitamin D (25-hydroxyvitamin D) status
Serum Vitamin D status (Week 12, 28 + 36 gestation) & cord serum Vitamin D status (delivery)

Secondary Outcome Measures

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

Full Information

First Posted
January 14, 2016
Last Updated
February 28, 2023
Sponsor
University of Ulster
Collaborators
Western Health and Social Care Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02713009
Brief Title
Impact of Maternal Body Weight on Vitamin D Status During Pregnancy
Acronym
MO-VITD
Official Title
Investigation of the Impact of Maternal Body Weight on Vitamin D Status During Pregnancy: a Randomised Supplementation Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
Collaborators
Western Health and Social Care Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Vitamin D Deficiency
Keywords
Maternal body weight, Vitamin D, Pregnancy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
Pregnancy multivitamin + vitamin D daily from ~Week 12 gestation until delivery
Arm Title
Treatment 2
Arm Type
Placebo Comparator
Arm Description
Pregnancy multivitamin + placebo daily from ~Week 12 gestation until delivery
Intervention Type
Dietary Supplement
Intervention Name(s)
Pregnancy multi-vitamin (including 10μg vitamin D3)
Intervention Type
Dietary Supplement
Intervention Name(s)
10μg vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
0μg vitamin D (placebo)
Primary Outcome Measure Information:
Title
Change in Vitamin D (25-hydroxyvitamin D) status
Description
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 + Delivery)
Secondary Outcome Measure Information:
Title
Gestational weight gain
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation)
Title
Change in inflammation status
Description
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)
Title
Change in bone turnover markers
Description
Plasma bone turnover markers (Week 12, 28 + 36 gestation) & cord plasma bone turnover markers (delivery)
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Title
Genetics
Description
e.g. CYP2R1, CYP27B1, CYP24A1
Time Frame
Baseline (Week 12 gestation)
Title
Dietary intake
Description
Food diary with food frequency questionnaire
Time Frame
Week 28 gestation
Title
Foetal growth chart measurement
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Title
Change in Vitamin D related measures
Description
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)
Title
Haemoglobin
Description
As part of full blood count
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Title
Plasma ferritin
Description
Clinical chemistry analyser
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Title
Transferrin saturation
Description
Clinical chemistry analyser
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Title
Iron status
Description
Serum, clinical chemistry analyser
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Title
Soluble transferrin receptor
Description
ELISA
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Title
Hepcidion
Description
ELISA
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)
Title
Methylation analysis
Description
Iron and vitamin D related genes
Time Frame
Baseline (Week 12 gestation), Mid-point (Week 28 gestation) & End of pregnancy (Week 36 gestation + Delivery)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Western Health and Social Care Trust, Altnagelvin
City
Londonderry
State/Province
Co.Londonderry
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
33964855
Citation
Alhomaid RM, Mulhern MS, Strain J, Laird E, Healy M, Parker MJ, McCann MT. Maternal obesity and baseline vitamin D insufficiency alter the response to vitamin D supplementation: a double-blind, randomized trial in pregnant women. Am J Clin Nutr. 2021 Sep 1;114(3):1208-1218. doi: 10.1093/ajcn/nqab112.
Results Reference
derived

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Impact of Maternal Body Weight on Vitamin D Status During Pregnancy

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