Vitamin D in Pregnancy and Lactation
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vitamin D Deficiency |
Drug: Vitamin D Drug: Vitamin D3 |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Vitamin D Dose-response Study Throughout Pregnancy and Lactation |
- 25(OH)D Plasma Concentrations [ Time Frame: 18 weeks gestation for mother ] [ Designated as safety issue: No ]
- 25(OH)D Plasma Concentrations [ Time Frame: 28 weeks gestation for mother ] [ Designated as safety issue: No ]
- 25(OH)D Plasma Concentrations [ Time Frame: 36 weeks gestation for mother ] [ Designated as safety issue: No ]
- 25(OH)D Plasma Concentrations [ Time Frame: 16 weeks post-partum for mother & infant ] [ Designated as safety issue: No ]
| Enrollment: | 225 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | February 2013 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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.
|
| Experimental: 2 |
Drug: Vitamin D3
25 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
|
| Experimental: 3 |
Drug: Vitamin D
50 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
|
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| Ages Eligible for Study: | 18 Years to 42 Years |
| Genders Eligible for Study: | Female |
| Accepts 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).
Contacts and Locations| Canada, British Columbia | |
| BC Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Principal Investigator: | Tim Green, Dr. | University of British Columbia |
| Study Director: | 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 Chair: | Russ Freisen, MSc | University of British Columbia |
| Study Chair: | Kaitlin March | University of British Columbia |
| Study Chair: | Tina Li | University of British Columbia |
More Information
No publications provided
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01112891 History of Changes |
| Other Study ID Numbers: | H09-01261, F08-03892 |
| Study First Received: | April 27, 2010 |
| Last Updated: | October 26, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
Vitamin D Infant Lactation Dose-Response |
Additional relevant MeSH terms:
|
Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Cholecalciferol Vitamin D |
Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 16, 2013