A Randomized Controlled Trial Comparing Two Regimens of Vitamin D Supplementation in Preterm Neonates
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Compare the level of serum 25 hydroxy vitamin D between the two groups of newborns. 2- Detect vitamin D deficiency among both groups.
研究概览
简要总结
randomized clinical trial comparing two different doses of vitamin d supplementation in preterm infants
详细描述
after randomization each group of preterm neonates (28-32) weeks consisting of 40 neonates
within 48 hrs of birth baseline ca.phosphorus, alkaline phosphatase and vitamin D level were withdrawn from each neonate
then babies started to take oral vitamin d in different doses (400 IU /day in the 1st group and 1000 iu per day in the 2nd group) after they reach 100 cc per kg per day enteral feeding
after they complete 40th week gestational age the investigators repeat the labs again ( serum ca, phosphorus,alp and vitamin D and compare the rate of rise in vitamin D and calcium
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm infants delivered at a gestational age ≤ 32 weeks
- •Birth weight ≤1500 kg
排除标准
- •Neonates with major congenital anomalies,
- •maternal condition or medications likely to influence vitamin D or calcium metabolism
- •neonates not receiving 100 ml/ kg / day of enteral feeds by 14 days of life
研究组 & 干预措施
400 iu
neonates who will receive vitamin d dose at 400 iu per day
干预措施: vitamin D (Dietary Supplement)
1000 iu
neonates who will receive vitamin d dose 1000 iu per day
干预措施: vitamin D (Dietary Supplement)
结局指标
主要结局
Compare the level of serum 25 hydroxy vitamin D between the two groups of newborns. 2- Detect vitamin D deficiency among both groups.
时间窗: 1 month
measurement of the level after supplementation
次要结局
未报告次要终点
研究者
Dina Jamal Abd elmoez abd elmegeed Basta
Principal investigator
Cairo University