A Randomized Controlled Trial on the Effect of 400 vs. 800 IU of Vitamin D on T Regulatory Cells in Preterm Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Percent Change in The Number of T Regulatory Cells
研究概览
简要总结
This study evaluate the effect of two different doses of vitamin D on T-regulatory cells in preterm infants. Half of the subjects receives 400 IU vitamin D and the other half receives 800 IU vitamin D.
详细描述
Vitamin D, in addition to its bone mineralization effect, is an immune- modulatory agent. Fetal and premature cellular immunity are generally delayed. Whether vitamin D can enhance cellular immunity by increasing T regulatory cells is unknown. The effect of two different doses of vitamin D; 400 IU and 800 IU will be studied.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with gestational age 28-33 weeks
排除标准
- •Necrotizing enterocolitis
- •Bowel perforation
- •Chromosomal anomalies
- •Inborn errors of metabolism
- •Major congenital anomalies
研究组 & 干预措施
Low dose
Subjects in this group receive 400 IU vitamin D daily for 4 weeks.
干预措施: Vitamin D (Drug)
High dose
Subjects in this group receive 800 IU vitamin D daily for 4 weeks.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Percent Change in The Number of T Regulatory Cells
时间窗: At 4 weeks (compared to baseline)
Flow cytometry assessment of CD4+ , CD25+ with expression of FOXP3 will be used to identify T Regulatory cells
次要结局
未报告次要终点
研究者
Lamiaa Mohsen
professor of Pediatrics
Cairo University