Title
Trial to Assess Vitamin D Requirements in Lactating Women
Randomised Placebo-controlled Supplementation Study With Vitamin D and Calcium in Breastfeeding Mothers
Phase
N/ALead Sponsor
National University of IrelandStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Vitamin D Insufficiency ...Intervention/Treatment
vitamin d3 calcium ...Study Participants
136This is a randomized, placebo-controlled trial of vitamin D supplementation with 20mcg cholecalciferol (to achieve a total intake of 25mcg/day), with or without 500mg calcium to assess vitamin D requirements in lactating women and to ascertain whether vitamin D supplementation at levels sufficient to achieve defined thresholds of maternal serum 25-hydroxyvitamin D will increase the vitamin D content of maternal milk. The study will also report serum 25-hydroxyvitamin D in maternal-cord dyads over a 12-month period and describe the relationship between them. Information on maternal iPTH levels, anthropometry, diet and sun exposure will also be reported.
20µg (800IU) of vitamin D3/day for 12-weeks while lactating, commencing 10-14 days post-partum.
20µg (800IU) of vitamin D3 + 500mg calcium carbonate/day for 12-weeks while lactating, commencing 10-14 days post-partum.
One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.
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).
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.
