Vitamin D in Pregnancy and Lactation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01112891
First received: April 27, 2010
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
Drug: Vitamin D
Drug: Vitamin D3
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Vitamin D Dose-response Study Throughout Pregnancy and Lactation

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 25(OH)D Plasma Concentrations [ Time Frame: 18 weeks gestation for mother ] [ Designated as safety issue: No ]
  • 25(OH)D Plasma Concentrations [ Time Frame: 28 weeks gestation for mother ] [ Designated as safety issue: No ]
  • 25(OH)D Plasma Concentrations [ Time Frame: 36 weeks gestation for mother ] [ Designated as safety issue: No ]
  • 25(OH)D Plasma Concentrations [ Time Frame: 16 weeks post-partum for mother & infant ] [ Designated as safety issue: No ]

Enrollment: 225
Study Start Date: March 2010
Estimated Study Completion Date: February 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Vitamin D
10 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
Experimental: 2 Drug: Vitamin D3
25 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
Experimental: 3 Drug: Vitamin D
50 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.

Detailed Description:

Purpose & Hypothesis: This project aims to determine maternal and infant responses vitamin D supplementation in pregnancy and lactation. It is hypothesized that the current AI of 5 μg of vitamin D will be inadequate for women and their infants in Canada to achieve optimal 25OHD concentrations (> 75nmol/L).

Methods: Healthy pregnant women between 18-42 years of age without history of pregnancy complications will be recruited for a double-blind, randomized, controlled trial where they will receive one of three different dosages of vitamin D (10, 25 and 50ug/day) as part of a standard prenatal vitamin. The study at 18 plus/minus 3 weeks gestation and will carry on throughout pregnancy and lactation. Mother and infant vitamin D levels in breast milk and blood will be measured at regular intervals. Skin colour will be measured via light reflectometry. Bone biomarkers such as plasma osteocalcin and urinary n-telopeptide will be assessed. Dietary vitamin D intake and sun exposure will be estimated using a food frequency and lifestyle questionnaire. Data will be analyzed using multiple regression analysis controlling for baseline values.

Expected Results & Conclusions: It is expected that greater vitamin D intakes (25, 50ug/day) will be necessary to raise maternal and infant serum concentrations to 25OHD>75nmol/L to avoid infant supplementation. This data will aid policy makers, mothers and healthcare workers in recommended and appropriate vitamin D dosage throughout pregnancy and lactation.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112891

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Tim Green, Dr. University of British Columbia
Study Director: 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 Chair: Russ Freisen, MSc University of British Columbia
Study Chair: Kaitlin March University of British Columbia
Study Chair: Tina Li University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01112891     History of Changes
Other Study ID Numbers: H09-01261, F08-03892
Study First Received: April 27, 2010
Last Updated: October 26, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Vitamin D
Infant
Lactation
Dose-Response

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on April 22, 2014