Stoss Therapy Versus Weekly Regimen of Vitamin D in Treatment of Children With Chronic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Vitamin D3 level after each regimen
研究概览
简要总结
The primary aim is to assess the efficacy of two different Vitamin D regimes in the treatment of vitamin D deficiency in children with chronic liver disease. The secondary aim is to evaluate the effect of vitamin D on liver fibrosis utilizing fibroscan..
详细描述
• In this study, the investigators are going to find out the optimum regimen to be used for effective treatment of vitamin D deficiency in those patients and to study the effect of vitamin D treatment on liver fibrosis.
Vitamin D is a hormone involved in the regulation of mineral homeostasis. It protects skeletal integrity and modulates cell growth and differentiation . It is lipid soluble in nature and interacts with vitamin D receptors and regulates the expression of more than 200 genes, mostly involved in apoptosis, cell growth, and cell differentiation .
Fibroscan: as a non-invasive imaging study for measuring liver cirrhosis by transducer probe-induced elastic share wave that propagates through liver tissue to measure its velocity. It is a promising noninvasive method for detection of cirrhosis in patients with chronic liver disease. Therefore, fibroscan can be used regarding the decision of treatment and follow-up of patients with cirrhosis for screening and detection of the complications . In our study the investigators will assess liver fibrosis before and after vitamin D therapy using fibroscan.
Group A: who received stoss parenteral vitamin D therapy (200.000 IU) once followed by 600 IU/ day orally (equivalent to RDA as maintenance).
Group B: who received 50.000 IU/ week vitamin D orally for four weeks followed by the maintenance dose.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children below the age of 18 with chronic liver disease.
排除标准
- •Patients with concomitant renal affection.
- •Patients who are on anticonvulsant therapy.
- •Patients who lost follow up
- •Patients refuse to participate at any time throughout the study period.
- •Non-compliant patients for more than 50% of time.
研究组 & 干预措施
Group A
Group A: Stoss vitamin D therapy
干预措施: Vitamin D (Drug)
Group B
Group B: Oral vitamin D therapy .
干预措施: Vitamin D (Drug)
结局指标
主要结局
Vitamin D3 level after each regimen
时间窗: six months
Quantitative estimation of 25(OH)D level was done using enzyme-linked immunoassay (ELISA) before and after therapy will be done.
次要结局
- Assessment of liver fibrosis by fibroscan(six months)
研究者
Hebatallah Saad Mahmoud Ahmed
Assisstant lecturer of pediatrics ,Ain shams university
Ain Shams University