The Impact of the Dose of Vitamin D (vitD) on the Metabolism of ca, p and Concentrations of 25OHD, Bone Status and Development of Premature Infants up to 2 Years of Age. Prospective, Randomized, Clinical Study
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Serum 25OHD levels in cord blood in Polish preterm infants
研究概览
简要总结
It has not yet been established the optimal dose of vit. D for preterm infants in Poland. It is not known what dose of vit. D will provide the correct concentration of vit. D and the optimal development of the skeleton of the premature.
The study will try to determine the optimal supplementation of vitamin D and the supply of Ca and P for normal growth and development of a child born prematurely.
In addition, the investigators will evaluate any risk factors for deficiency and excess of vitamin D and the consequences of its deficiency and overdose. Simultaneously the study would make possible the determination of an optimal schedule for controlling the Ca-P levels in the group of the youngest infants born prematurely. In addition, the study will assess the relationship between maternal and newborn vitamin D resources right after birth, and the incidence of vitamin D deficiency in infants born prematurely. Preterm infants will be randomized in 3 groups assigned to different doses of vit. D. The study will investigate the metabolism of calcium, phosphorus, the health of bones and development of the premature babies till the age of 2.
详细描述
The participants of the study will be prematures, born ≤32 GA, hospitalized in the Department of Neonatology, in the neonatal intensive care unit. Hospitalized patients who meet the inclusion criteria will be randomized in 3 groups assigned to different doses of vit. D (400, 800 or 1200 units(UNT) of vitamin D).
At defined age points of postnatal life, parameters of calcium and phosphorus metabolism and vitamin D level will be tested, along with the health of bones, health status and development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age ≤32 weeks at birth
- •hospitalization in the department no later than at the age of 7 days (for infants born outside the center)
- •No birth defects or diseases permanently affecting the ability to accept enteral feeding
- •Anticipated possibility of continuous monitoring of the course of treatment in hospital until discharge
- •Consent of Parents / legal guardians for the participation in the study.
- •Exclusion criteria
- •gestational age> 32 weeks at birth
- •the beginning of hospitalization in the department later than the age of 7 days (for infants born outside the center)
- •presence of congenital defects or diseases permanently affecting the ability to accept enteral feeding (e.g.oesophageal atresia, anal atresia, congenital umbilical hernia, gastroschisis, syndromes genetically determined)
- •significant interruption (> 1 week) of the hospitalization in the center
- •lack of consent of the Parents / legal guardians to participation in the study
排除标准
- 未提供
研究组 & 干预措施
Lower dose
cholecalciferol 400UNT, oral solution
干预措施: Cholecalciferol 400 (Dietary Supplement)
Middle dose
cholecalciferol 800UNT, oral solution
干预措施: Cholecalciferol 800 (Dietary Supplement)
Higher dose
cholecalciferol 1200UNT, oral solution,
干预措施: Cholecalciferol 1200 (Drug)
结局指标
主要结局
Serum 25OHD levels in cord blood in Polish preterm infants
时间窗: day of labour
assessment of 25OH D levels in children deficiency: \<10ng/ml, insufficient level: 10-30ng/ml, sufficient level: 30-50ng/ml
次要结局
- Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary Ca excretion(4,8,12 weeks of life,1 and 2 years of age)
- Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on urinary P excretion(4,8,12 weeks of life,1 and 2 years of age)
- impact of total annual Vit D3 dose and bone calcification in children(average of 1 and 2 years of age)
- Impact of dosage of Vit D3 (400/800/1200 UNT per day) on serum 25OH D levels in preterm children(4,8,12 weeks of life,1 and 2 years of age)
- Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on P serum levels(4,8,12 weeks of life,1 and 2 years of age)
- impact of cord blood 25OHD level on birth weight(1st day of life of age)
- Impact of supplementation of Vit. D during pregnancy on 25OHD serum level in Polish mothers(day of labour)
- Impact of dosage of Vit D3 (400/800/1200 UNT /per day) on Ca serum levels(4,8,12 weeks of life,1 and 2 years of age)
- correlation of cord blood 25OHD level and GA(1st day of life)
研究者
Maria Wilinska
Head Of Neonatology
Centre of Postgraduate Medical Education