Trial to Assess Vitamin D Requirements in Lactating Women

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 136
• Participant gender: Female

Summary

This 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University College Cork
• Collaborator: Irish Government Department of Agriculture, Food and Fisheries, Ireland
• Treatments: Calcium Carbonate; Calcium, Dietary; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins
• Last Updated: 2011-05-05

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.