Vitamin D in Pregnancy and Lactation
|ClinicalTrials.gov Identifier: NCT01112891|
Recruitment Status : Completed
First Posted : April 29, 2010
Last Update Posted : December 16, 2014
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Drug: Vitamin D Drug: Vitamin D3||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Vitamin D Dose-response Study Throughout Pregnancy and Lactation|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||February 2013|
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.
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.
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.
- 25(OH)D Plasma Concentrations [ Time Frame: 18 weeks gestation for mother ]
- 25(OH)D Plasma Concentrations [ Time Frame: 28 weeks gestation for mother ]
- 25(OH)D Plasma Concentrations [ Time Frame: 36 weeks gestation for mother ]
- 25(OH)D Plasma Concentrations [ Time Frame: 16 weeks post-partum for mother & infant ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112891
|Canada, British Columbia|
|BC Children's Hospital|
|Vancouver, British Columbia, Canada, V6H 3V4|
|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|