Randomised Placebo-controlled Supplementation Study With Vitamin D and Calcium in Breastfeeding Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Serum 25-hydroxyvitamin D in mothers and levels of vitamin D in maternal milk
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Serum 25-hydroxyvitamin D in mothers and levels of vitamin D in maternal milk
时间窗: 12 weeks
Baseline and endpoint serum 25(OH)D analysis in mothers (week 0 and week 12); baseline, week 4, week 8 and enpoint analysis of vitamin D3, D2 and 25(OH)D in expressed breast milk (hindmilk samples)
次要结局
- Maternal serum iPTH(12 weeks)
研究者
Mairead Kiely PhD
Professor of HUman Nutrition
University College Cork