Vitamin D in Pregnancy and Lactation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vitamin D Dose-response Study Throughout Pregnancy and Lactation

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D
* Drug: Vitamin D3
* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Vitamin D<br>* 10 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.<br>|
| Experimental: 2<br> | Drug: Vitamin D3<br>* 25 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.<br>|
| Experimental: 3<br> | Drug: Vitamin D<br>* 50 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Infant, Lactation, Dose-Response