NCT02713009

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

January 14, 2016

Last Update Submit

February 28, 2023

Conditions

ObesityVitamin D Deficiency

Keywords

Maternal body weightVitamin DPregnancy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • Gestational weight gain

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

  • Change in inflammation status

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

  • Change in bone turnover markers

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

  • Genetics

    Baseline (Week 12 gestation)

  • Dietary intake

    Week 28 gestation

  • +9 more secondary outcomes

Study Arms (2)

Treatment 1

EXPERIMENTAL

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

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

Treatment 2

PLACEBO COMPARATOR

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

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

Interventions

Pregnancy multi-vitamin (including 10μg vitamin D3)DIETARY_SUPPLEMENT
Treatment 1Treatment 2
10μg vitamin D3DIETARY_SUPPLEMENT
Treatment 1
0μg vitamin D (placebo)DIETARY_SUPPLEMENT
Treatment 2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Health and Social Care Trust, Altnagelvin

Londonderry, Co.Londonderry, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33964855DERIVED

MeSH Terms

Conditions

ObesityVitamin D Deficiency

Interventions

CholecalciferolVitamin D

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutrition

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

March 18, 2016

Study Start

November 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 3, 2023

Record last verified: 2023-02

Locations

GB(1)