Supplementation of Vitamin D in Preterm Infants- Monitored Therapy vs Standard Therapy. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Number of Participants with D- deficiency or access
研究概览
简要总结
The purpose of this study is to determine wheather the monitored vitamin D (vit D) therapy is safer and more effective than standard therapy in pretrem infants.
详细描述
Vitamin D (vit D) deficiency is a risk factor of osteopenia of prematurity, which leads to rickets or decreased bone mass mineral density. Recently multiple studies have been published on vit D adjust biological functions. Dosage, safety and effectiveness of vitD supplementation in preterm infants still remains a controversial topic. We hypothesize that monitored supplementation of vit D is more effective and safer than standard therapy 500IU in preterm infants. The study will be carried out in 138 preterm infants, born at 24-32 week of gestational age (GA) at the Princess Anne's Hospital in Warsaw, Poland. We will determine if monitored supplementation of vit D decreases the incidence of vit D deficiency and/or overdosing at 40 week (GA). For secondary objective we shall assess if monitored therapy reduces the incidence of vit D deficiency and/or overdosing at 35, 52 week (GA), prevalence of osteopenia, low bone mass, nephrocalcinosis and nephrolithiasis.
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
- None
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born between 24 and 32 weeks of gestation (estimated by ultrasound)
- •In born or admitted to the unit within 48hours from birth.
- •Randomization within 7 days from birth.
- •Parental consent.
- •Mothers willing to return for follow up visits.
排除标准
- •Preterm delivery >=33 weeks of gestation or term delivery (estimated by ultrasound).
- •Major congenital abnormalities.
- •Participation in another trial.
- •Severe illness at birth deemed incompatible with survival.
- •Congenital HIV infection.
- •Total parenteral nutrition > 14 days.
- •Cholestasis
结局指标
主要结局
Number of Participants with D- deficiency or access
时间窗: At 52 (+/-2 weeks) PMA (postmenstrual age)
25-hydroxyvitamin D serum level below 20ng/ml (50nmol/l ) or above 100ng/ml (250nmol/l )
次要结局
- Number of Participants with biochemical markers of osteopenia(at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age))
- average of bone mass(at 35, 40 (+/-2 weeks) PMA)
- Number of Participants with hypercalcemia(at 35, 40, 52 (+/-2 weeks) PMA (postmenstrual age))
- Number of Participants with hypercalcuria(at 35, 40, 52 (+/-2 weeks) PMA)
- Number of Participants with nephrocalcinosis(at 35, 52 (+/-2 weeks) PMA)
研究者
Alicja Kołodziejczyk
PhD student
Princess Anna Mazowiecka Hospital, Warsaw, Poland