A Prospective Observational Study: Connection Between Vitamin D Level and the Efficacy of Dexamethasone in Immune Thrombocytopenia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Sustained response to ITP treatments
研究概览
简要总结
The project was undertaking by Qilu Hospital of Shandong University in China. The objective is to find out if there is a connection between vitamin D level and the efficacy of dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
详细描述
The investigators anticipate to undertaking a prospective, observational，non-randomized control trial of 60 ITP adult patients. Dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days) will be used in the target patients. Vitamin D level will be detected before the utilization of treatment measures. Depend on the vitamin D level, the patients will be divided into 2 groups(higher vitamin D level group and lower vitamin D level group).Platelet count, bleeding and other symptoms were evaluated before and after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Corresponding to the diagnostic criteria for immune thrombocytopenia Newly diagnosed ITP patients To show a platelet count <30 * 10^9/L, and with bleeding manifestations Willing and able to sign written informed consent
排除标准
- •Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit; Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study; Current HIV infection; Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test; Patients who are deemed unsuitable for the study by the investigator.
研究组 & 干预措施
Lower vitamin D level group
The vitamin D level is lower than 20 nmol/L.
干预措施: Dexamethasone (Drug)
Higher vitamin D level group
The vitamin D level is higher than 20 nmol/L.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Sustained response to ITP treatments
时间窗: 3 months after treatment started
Percentage of patients maintaining PLT count over 30\*10\^9/L without bleeding
次要结局
未报告次要终点
研究者
Ming Hou
Professor
Shandong University