Evaluation of the Role of Vitamin D in Reducing the Severity and Duration of Rotavirus Infection in Iraqi Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Severity of diarrhea
研究概览
简要总结
The aim of this study is to evaluate the effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital. And to evaluate the anti-inflammatory effect of vitamin D on the pediatrics with rotavirus gastroenteritis by measuring inflammatory markers such as C-reactive protein (CRP), neutrophil to lymphocyte ratio (NLR), platelet to lymphocytes ratio (PLR), lymphocytes to monocytes ratio (LMR) and mean platelet volume MPV.
详细描述
Evaluation of effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital. And to evaluate the anti-inflammatory effect of vitamin D on the pediatrics with rotavirus gastroenteritis by measuring inflammatory markers such as C-reactive protein (CRP), neutrophil to lymphocyte ratio (NLR), platelet to lymphocytes ratio (PLR), lymphocytes to monocytes ratio (LMR) and mean platelet volume MPV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children with confirmed rotavirus infection by rotavirus stool examination by rotavirus rapid test from CerTest BIOTEC company in Spain.
- •Serum vitamin D levels indicating deficiency (below 20 ng/mL)
排除标准
- •Children with other major infections, severe dehydration or underlying health conditions.
- •Children with current vitamin D supplementation.
研究组 & 干预措施
Group I (control): received standard treatment which include rehydration therapy and antipyretic the
Group I (control): will receive standard treatment which include rehydration therapy and antipyretic therapy
干预措施: Standard treatment for rotavirus (Drug)
Group II (Treatment) group: received vitamin D single oral dose 300000 IU for age < 1 year and dose
Group II (Treatment) group: received vitamin D single oral dose 100000 IU for age < 1 year and dose of 300000IU for age> 1 year in addition to standard treatment. The study lasted 6 months, with follow-ups at 7-10 days
干预措施: Vitamin D (Cholecalciferol ) (Dietary Supplement)
结局指标
主要结局
Severity of diarrhea
时间窗: 7 days
severity of diarrhea will be measured by frequency of daily bowel movement
Duration of diarrhea
时间窗: 7 days
Duration of diarrhea will be measured by days
Severity of vomiting
时间窗: 7 days
Severity of vomiting will be measured by frequency of vomiting per day
Duration of vomiting
时间窗: 7 days
Duration of vomiting will be measured by days
Hydration state
时间窗: 7 days
Hydration state will be measured by score (1 fore well hydrated,2 for mild dehydration, 3 for moderate dehydration and 4 for severe dehydration)
Temperature
时间窗: 7 days
Temperature will be measured by nominal scale (1 for febrile and 0 fir afebrile patient)
次要结局
- Measuring LMR at admission, after 4 days and after 7 days both groups.(7 days)
- C reactive protein (CRP)(7 days)
- Mean platelet volume (MPV)(7 days)
- Measuring NLR at admission, after 4 days and after 7 days both groups.(7 days)
- Measuring PLR at admission, after 4 days and after 7 days both groups.(7 days)
研究者
Fadia Thamir Ahmed
Lecturer/ College of Pharmacy/ University of Baghdad
University of Baghdad