Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F08-03892 | Other Grant/Funding Number | CIHR |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | 10 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tim Green, Dr. | University of British Columbia | Principal Investigator |
| 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 Director |
| Russ Freisen, MSc | University of British Columbia | Study Chair |
| Kaitlin March | University of British Columbia | Study Chair |
| Tina Li | University of British Columbia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39077939 | Derived | Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5. | |
| 29901753 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vitamin D3 | Drug | 25 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum. |
|
| Vitamin D | Drug | 50 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum. |
|
| 26156737 | Derived | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |