Clinical trial NCT01112891: Vitamin D in Pregnancy and Lactation
Official title: Vitamin D Dose-response Study Throughout Pregnancy and Lactation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: Vitamin D
Infant
Lactation
Dose-Response
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-04-29
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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).

Primary outcomes:
measure: 25(OH)D Plasma Concentrations
timeFrame: 18 weeks gestation for mother
measure: 25(OH)D Plasma Concentrations
timeFrame: 28 weeks gestation for mother
measure: 25(OH)D Plasma Concentrations
timeFrame: 36 weeks gestation for mother
measure: 25(OH)D Plasma Concentrations
timeFrame: 16 weeks post-partum for mother & infant
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Tim Green, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Sheila M. Innis, Dr.
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Michael R. Lyon, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Antonia W. Shand, Dr
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Peter von Dadelszen, MD
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Russ Freisen, MSc
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Kaitlin March
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Tina Li
role: STUDY_CHAIR
References:
citation: Stamm RA, March KM, Karakochuk CD, Gray AR, Brown RC, Green TJ, Houghton LA. Lactating Canadian Women Consuming 1000 microg Folic Acid Daily Have High Circulating Serum Folic Acid Above a Threshold Concentration of Serum Total Folate. J Nutr. 2018 Jul 1;148(7):1103-1108. doi: 10.1093/jn/nxy070.
citation: March KM, Chen NN, Karakochuk CD, Shand AW, Innis SM, von Dadelszen P, Barr SI, Lyon MR, Whiting SJ, Weiler HA, Green TJ. Maternal vitamin D(3) supplementation at 50 mug/d protects against low serum 25-hydroxyvitamin D in infants at 8 wk of age: a randomized controlled trial of 3 doses of vitamin D beginning in gestation and continued in lactation. Am J Clin Nutr. 2015 Aug;102(2):402-10. doi: 10.3945/ajcn.114.106385. Epub 2015 Jul 8.