Use of Vitamin D as An Adjuvant Treatment in Children With Chronic Idiopathic Thrombocytopenic Purpura
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Participants who receive vitamin D will show change platelet count more than placepo group
研究概览
简要总结
Immune thrombocytopenia is an autoimmune disease in which platelets are targeted by the host immune system. Platelet depletion occurs when autoantibodies targeting glycoproteins (αIIb-β3 and GPIb) found on the surface of platelets opsonize the cells, resulting in destruction by macrophages. These antibodies can also bind to megakaryocytes and prevent complete maturation, which results in lowered levels of platelet production Vitamin D (VD) or 1,25-dihydroxyvitamin D, may be a potent immunomodulator, and it may have potential therapeutic use in many autoimmune diseases In 1991, researchers found that the production of interleukin (IL)-6 and IL-2 in cell cultures were reduced by 1,25(OH)2D3 VD deficiency is very common in children with either newly diagnosed or chronic ITP form.Correlation between hypovitaminosis D and a higher incidence of infections and autoimmune diseases was reported as well Case-Control interventional study (over time each participant will be randomized to be enrolled in one of either study arms in a random sequence). To evaluate the efficacy of VD supplementation as an adjuvant therapy in chronic ITP children and its effect on platelet count and bleeding score.
The participants will be - Children from 1 year to 18 years diagnosed with Chronic ITP with platelet count <100,000/microL.
Patients groups will be:
Patients of Chronic ITP aged from 1year till 18 years old . in this study will be divided into 2 groups ● Group A : All patients with VIT D insufficiency(The preferred level for 25(OH)D is now recommended by many experts to be >30 ng/ml) will receive supplementary Vitamin D3(NIVAGEN Vitamin D3 Cholecalciferol 50000 IU) oral once weekly for 3 months as adjuvant therapy in combination with their treatment for ITP.
● Group B : patients in this group have sufficient VIT D level and will be divided into 2 groups :
- Group 1 B :will receive their standard treatment for ITP with VIT D.
- Group 2 B :will receive their standard treatment for ITP without VIT D. Complete blood picture will be made at the beginning of study then monthly to evaluate the number of platelets that expected to increase after VD supplementation
详细描述
Introduction
Immune thrombocytopenia is an autoimmune disease in which platelets are targeted by the host immune system. Platelet depletion occurs when autoantibodies targeting glycoproteins (αIIb-β3 and GPIb) found on the surface of platelets opsonize the cells, resulting in destruction by macrophages. These antibodies can also bind to megakaryocytes and prevent complete maturation, which results in lowered levels of platelet production.
ITP of childhood is characterized by isolated thrombocytopenia (platelet count <100,000/microL with normal white blood cell count, hemoglobin, and blood smear).
The incidence of ITP in children is approximately 4-8 per 100,000 person-year . A recent history of viral illness is described in 50-65% of children with ITP. The peak age is 1-4 yr. ITP seems to occur more often in late winter and spring after the peak season of viral respiratory illness.
ITP can be classified by disease duration into; newly diagnosed (0-3 months), persistent (>3-12 months), or chronic (>12 months). The term "refractory" has been used to refer to patients who failed to improved after splenectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chirdren from 1 year to 18 years.
- •Diagnosed with Chronic ITP .
- •Platelet count <100,000/microL.
排除标准
- •Other causes of thrombocytopenia.
- •Acute and persistant ITP.
- •Dysmorphic feature.
- •Patients with other comorbidities.
研究组 & 干预措施
chronic ITP children with VD level less than 30 ng/ml.
will receive VD 3 50000 IU per week for 3 months beside their treatment for ITP.
干预措施: VIT D (Drug)
chronic ITP children with VD level more than 30 ng/ml.
will receive VD 3 50000 IU per week for 3 months beside their treatment for ITP.
干预措施: VIT D (Drug)
结局指标
主要结局
Participants who receive vitamin D will show change platelet count more than placepo group
时间窗: 3 month
To evaluate the efficacy of VD supplementation as an adjuvant therapy in chronic ITP children and its effect on platelet count and bleeding score.
次要结局
未报告次要终点