Comparison Between Low and High Doses of Prophylactic Vitamin D in Prevention of Osteopenia of Prematurity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Calcium level and activity
研究概览
简要总结
In this study the effects of low and high doses of prophylactic vitamin D on biochemical and radiological manifestations of osetopenia of prematurity will be tested.
详细描述
The study will be conducted on (80) preterm infants that fulfill the eligibility criteria and delivered at Alexandria University Maternity Hospital (AUMH).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns with gestational age of ≤ 32 weeks and birth weight ≤ 1500 g.
排除标准
- •Newborns whose mothers were taking specific medications interacting with vitamin D metabolism (e.g., anticonvulsants, diuretics)
- •Being NPO (nothing per oral) for more than 2 wks
- •Gestational age more than 32 weeks
- •Birth weight more than 1500 grams
研究组 & 干预措施
200 IU/d vitamin D
Patients will receive low-dose vitamin D (200 IU/d)
干预措施: Low Dose Vitamin D (Drug)
1600 IU/d vitamin D
Patients will receive high-dose vitamin D (1600 IU/d)
干预措施: High Dose Vitamin D (Drug)
结局指标
主要结局
Calcium level and activity
时间窗: six weeks
Serum calcium level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 8.5 to 10.5 mg/dl
Phosphorus level and activity
时间窗: six weeks
Serum phosphorus level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 3.4 to 4.5 mg/dl
Alkaline phosphatase level and activity
时间窗: six weeks
Serum alkaline phosphate level will be measured and analyzed using Advia 1800 chemistry system (Simens Germany). Normal level: 50-100 U/L.
25-Hydroxy Vitamin D
时间窗: six weeks
Serum 25-Hydroxy Vitamin D level will be measured and analyzed using Electrochemilumiescence binding assay on cobas e immunoassay analyzer. The reference range of the total 25(OH)D level is 25-80 ng/mL.
Bone fracture
时间窗: six weeks
This will be evaluated using an x-ray of left wrist
Intracortical resorption
时间窗: six weeks
This will be evaluated using an x-ray of left wrist
Losing the sharp bone border (fraying)
时间窗: six weeks
This will be evaluated using an x-ray of left wrist
Cupping of metaphyseal edge of bone
时间窗: six weeks
This will be evaluated using an x-ray of left wrist
Widening of the distal end of the metaphysis of bone
时间窗: six weeks
This will be evaluated using an x-ray of left wrist
次要结局
未报告次要终点
研究者
Marwa Mohamed Farag
Lecturer in Pediatrics, Faculty of Medicine
Alexandria University