NCT02506439

Brief Summary

Randomised, placebo-controlled dose-response intervention study with vitamin D3 in pregnant women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

November 19, 2024

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

May 12, 2015

Last Update Submit

November 15, 2024

Conditions

Vitamin D Deficiency

Keywords

Vitamin DCholecalciferolDose-responseRandomized Controlled TrialPregnancyCord bloodSerum 25-hydroxyvitamin DVitamin D DeficiencyNutritionDietary intervention study

Outcome Measures

Primary Outcomes (1)

  • Serum 25-hydroxyvitamin D in pregnant women and cord blood

    Analysis of serum 25-hydroxyvitamin D in mothers for blood taken in the first, second and third trimesters and in umbilical cord

    Change from 1st through 2nd trimester and at delivery

Secondary Outcomes (2)

  • Serum total calcium

    Change from 1st through 2nd trimester and at delivery

  • Serum Parathyroid Hormone

    Change from 1st through 2nd trimester and at delivery

Study Arms (3)

10 mcg Vitamin D3

EXPERIMENTAL

White-skinned women will receive Cholecalciferol (Vitamin D3) 10 mcg \[400 IU\] daily

Dietary Supplement: 10 mcg Vitamin D3

20 mcg Vitamin D3

EXPERIMENTAL

White-skinned women will receive Cholecalciferol (Vitamin D3) 20 mcg \[800 IU\] daily

Dietary Supplement: 20 mcg Vitamin D3

Placebo

PLACEBO COMPARATOR

White-skinned women will receive a Placebo supplement, identical in appearance and taste to the active product

Dietary Supplement: Placebo

Interventions

10 mcg Vitamin D3DIETARY_SUPPLEMENT

Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

Also known as: Cholecalciferol
10 mcg Vitamin D3
20 mcg Vitamin D3DIETARY_SUPPLEMENT

Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

Also known as: Cholecalciferol
20 mcg Vitamin D3
PlaceboDIETARY_SUPPLEMENT

Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)

Also known as: Placebo capsule
Placebo

Eligibility Criteria

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

You may qualify if:

  • Adult (\>18 years)
  • No more than 18 weeks gestation
  • In good general health
  • Low risk pregnancy
  • Not consuming \>10 mcg/d vitamin D from supplements

You may not qualify if:

  • Current smokers
  • Diagnosed hypertension
  • Known high-risk pregnancy
  • Diagnosed medical illness including diabetes mellitus (Types 1 \& 2), chronic kidney disease or gastro-intestinal diseases or any illness known to interfere with calcium metabolism (e.g. sarcoidosis).
  • Consumption of medications known to interfere with vitamin D metabolism
  • Consumption of vitamin D (≥ 10 µg/day) or calcium (≥ 650 mg/d) supplements prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cork University Maternity Hospital and University College Cork

Cork, Ireland

Location

Human Nutrition Resource Unit, School of Food and Nutritional Sciences, University College Cork

Cork, Ireland

Location

Related Publications (2)

  • Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.

    PMID: 39077939DERIVED

  • O'Callaghan KM, Hennessy A, Hull GLJ, Healy K, Ritz C, Kenny LC, Cashman KD, Kiely ME. Estimation of the maternal vitamin D intake that maintains circulating 25-hydroxyvitamin D in late gestation at a concentration sufficient to keep umbilical cord sera >/=25-30 nmol/L: a dose-response, double-blind, randomized placebo-controlled trial in pregnant women at northern latitude. Am J Clin Nutr. 2018 Jul 1;108(1):77-91. doi: 10.1093/ajcn/nqy064.

    PMID: 29878035DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Mairead Kiely, PhD

    University College Cork

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Human Nutrition

Study Record Dates

First Submitted

May 12, 2015

First Posted

July 23, 2015

Study Start

November 1, 2014

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

November 19, 2024

Record last verified: 2024-11

Locations

IE(2)