Skip to content

Vitamin D in Pregnancy and Lactation

Vitamin D Dose-response Study Throughout Pregnancy and Lactation

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01112891
Enrollment
225
Registered
2010-04-29
Start date
2010-03-31
Completion date
2013-02-28
Last updated
2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

Vitamin D, Infant, Lactation, Dose-Response

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.

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.

Interventions

DRUGVitamin D

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

DRUGVitamin D3

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

Sponsors

University of British Columbia
Lead SponsorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
25(OH)D Plasma Concentrations18 weeks gestation for mother

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026