Vitamin D in Pregnancy and Lactation

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Dose-response Study Throughout Pregnancy and Lactation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01112891
• Other study ID #: H09-01261
• Secondary ID: F08-03892
• Status: Completed
• Phase: Phase 4
• First received: April 27, 2010
• Last updated: December 12, 2014
• Start date: March 2010
• Est. completion date: February 2013

Study information

• Verified date: December 2014
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: February 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

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.
• Vitamin D3
25 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
• Vitamin D
50 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25(OH)D Plasma Concentrations		18 weeks gestation for mother	No
Primary	25(OH)D Plasma Concentrations		28 weeks gestation for mother	No
Primary	25(OH)D Plasma Concentrations		36 weeks gestation for mother	No
Primary	25(OH)D Plasma Concentrations		16 weeks post-partum for mother & infant	No