Trial to Assess Vitamin D Requirements in Lactating Women (DMUMs)
Vitamin D Deficiency, Vitamin D Insufficiency
About this trial
This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D, Cholecalciferol, Nutrient requirements, Randomised Controlled Trial, Lactation, pregnancy, Cord blood, Human milk, serum 25-hydroxyvitamin D, deficiency, insufficiency, nutrition
Eligibility Criteria
Inclusion Criteria:
- Pregnant women intending to breast feed their infant for at least 12-weeks
- Pregnant women >20 weeks gestation
- Pregnant women >18 years of age
- Pregnant women in good general health
Exclusion Criteria:
- Consumption of a vitamin D-containing supplement(>10µg/day) in the 3 months prior to commencing the trial
- Consumption of a vitamin D or calcium containing supplement during the 12- week trial
- Mothers taking a vacation to a sunny climate or using a solarium during the 12-week trial
- Mothers with pre-existing type 1 or type 2 diabetes
- Mothers with pre-existing hypertension
- Mothers with diagnosed hypercalcemia
- Mothers with diagnosed intestinal malabsorption conditions
- Mothers with multiple fetuses (e.g. twins)
- Consumption of medications known to interfere with vitamin D metabolism.
Sites / Locations
- School of Food & Nutritional Sciences, University College Cork,
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
20µg Vitamin D3
20µg Vitamin D3 + 500 mg Calcium
Placebo
Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol).
Arm will receive per day one gelatin capsule containing 20µg (800IU) of vitamin D3 (Cholecalciferol) and one tablet of calcium carbonate containing 500mg of calcium.
Arm will receive one gelatin capsule containing 0µg (0IU) of vitamin D3 (Cholecalciferol).