Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 10
- 主要终点
- serum 25-hydroxyvitamin D concentration,
研究概览
简要总结
The investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both.
The investigators also want to confirm that vitamin D supplementation of exclusively breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status independently of mother's vitamin D supplementation up to 1200 ID/d.
Additionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin D status of pregnant women at the delivery and their newborn infants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem
排除标准
- •Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.
- •Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.
结局指标
主要结局
serum 25-hydroxyvitamin D concentration,
时间窗: 3 time poits up to 6 months (0-3-6 months)
次要结局
- body composition measured by dual x-ray densitometry(3 time points up to 6 months (0-3-6months))
- serum calcium(2 time poits up to 6 months ( 3-6 months))
- calciuria (Urinary calcium and creatinine - UCa/crea)(2 time poits up to 6 months ( 3-6 months))
- iPTH(3 time poits up to 6 months (0-3-6 months))
- Prevalence of vitamin D deficiency (25OHD<20ng/ml)(3 time poits up to 6 months (0-3-6 months))
- Prevalence of vitamin D sufficiency (25OHD>30ng/ml)(3 time poits up to 6 months (0-3-6 months))
研究者
Justyna Czech-Kowalska
Deputy Head of Neonatology and Intensive Care, MD, PhD
Children's Memorial Health Institute, Poland