NCT01112891

Brief Summary

Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and baby reach a vitamin D serum concentration of 25OHD\>75nmol/L.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2010

Typical duration for phase_4

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

March 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 29, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

2.4 years

First QC Date

April 27, 2010

Last Update Submit

December 12, 2014

Conditions

Vitamin D Deficiency

Keywords

Vitamin DInfantLactationDose-Response

Outcome Measures

Primary Outcomes (4)

  • 25(OH)D Plasma Concentrations

    18 weeks gestation for mother

  • 25(OH)D Plasma Concentrations

    28 weeks gestation for mother

  • 25(OH)D Plasma Concentrations

    36 weeks gestation for mother

  • 25(OH)D Plasma Concentrations

    16 weeks post-partum for mother & infant

Study Arms (3)

1

EXPERIMENTAL
Drug: Vitamin D

2

EXPERIMENTAL
Drug: Vitamin D3

3

EXPERIMENTAL
Drug: Vitamin D

Interventions

Vitamin DDRUG

10 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.

1
Vitamin D3DRUG

25 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.

2

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women between 18-42 years of age
  • within 18 plus/minus 3 weeks gestation
  • planning to breastfeed their infant
  • a singleton pregnancy

You may not qualify if:

  • Any co-morbid condition such pre-gestational diabetes, TB, cardiac or renal disease, HIV/AIDS, chronic hypertension, inflammatory bowel disease, autoimmune disease, liver disease, or epilepsy; conditions associated with vitamin D malabsorption: celiac disease, gastric bypass;
  • History of previous adverse pregnancy outcome \[preterm delivery \<37; weeks GA, stillbirth, severe pre-eclampsia, eclampsia, HELLP syndrome (hemolytic anemia, elevated liver enzymes, and low platelet count)\];
  • Women will also be ineligible if they are taking more than 10 µg day supplemental vitamin D or drugs known to interfere with vitamin D metabolism (i.e corticosteroids).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (3)

  • 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

  • Stamm RA, March KM, Karakochuk CD, Gray AR, Brown RC, Green TJ, Houghton LA. Lactating Canadian Women Consuming 1000 microg Folic Acid Daily Have High Circulating Serum Folic Acid Above a Threshold Concentration of Serum Total Folate. J Nutr. 2018 Jul 1;148(7):1103-1108. doi: 10.1093/jn/nxy070.

    PMID: 29901753DERIVED

  • March KM, Chen NN, Karakochuk CD, Shand AW, Innis SM, von Dadelszen P, Barr SI, Lyon MR, Whiting SJ, Weiler HA, Green TJ. Maternal vitamin D(3) supplementation at 50 mug/d protects against low serum 25-hydroxyvitamin D in infants at 8 wk of age: a randomized controlled trial of 3 doses of vitamin D beginning in gestation and continued in lactation. Am J Clin Nutr. 2015 Aug;102(2):402-10. doi: 10.3945/ajcn.114.106385. Epub 2015 Jul 8.

    PMID: 26156737DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyBreast Feeding

Interventions

Vitamin DCholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipids

Study Officials

  • Tim Green, Dr.

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Sheila M. Innis, Dr.

    University of British Columbia

    STUDY DIRECTOR

  • Michael R. Lyon, MD

    University of British Columbia

    STUDY DIRECTOR

  • Antonia W. Shand, Dr

    University of British Columbia

    STUDY DIRECTOR

  • Peter von Dadelszen, MD

    University of British Columbia

    STUDY DIRECTOR

  • Russ Freisen, MSc

    University of British Columbia

    STUDY CHAIR

  • Kaitlin March

    University of British Columbia

    STUDY CHAIR

  • Tina Li

    University of British Columbia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 29, 2010

Study Start

March 1, 2010

Primary Completion

August 1, 2012

Study Completion

February 1, 2013

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

CA(1)