A Multicenter Randomized Study of Vitamin D Combined With HD-DXM Versus HD-DXM for the Treatment of ITP
Study Details
Study Description
Brief Summary
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of vitamin D combining with high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
The investigators anticipate to undertaking a prospective, multicenter, randomised controlled trial of 60 ITP adult patients. One part of the participants are randomly selected to receive vitamin D (given Rocaltrol orally at a dose of 0.25 μg per day for 1 month), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Serum calcium and creatinine are monitored. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of vitamin D combining with high-dose dexamethasone therapy for the treatment of adults with ITP.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Rocaltrol Combining HD-DXM Rocaltrol 0.25 μg once per day, 1 month; HD-DXM (orally at 40 mg daily for 4d ) |
Drug: Rocaltrol
Rocaltrol 0.25 μg daily for 1 month; HD-DXM (orally at 40 mg daily for 4d )
Other Names:
Drug: Dexamethasone
HD-DXM (orally at 40 mg daily for 4d )
|
| Active Comparator: HD-DXM HD-DXM (orally at 40 mg daily for 4d ) |
Drug: Rocaltrol
Rocaltrol 0.25 μg daily for 1 month; HD-DXM (orally at 40 mg daily for 4d )
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Sustained response to ITP treatments [3 months after treatment started]
Percentage of patients maintaining PLT count over 30*10^9 without bleeding
Secondary Outcome Measures
- Evaluation of platelet response [3 months after treatment started]
Complete response (CR)： A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding. Response (R)： A platelet count ≥ 30 * 10^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions > 7 days apart and the absence of bleeding. No response (NR)： A platelet count < 30 * 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
Suffered from diseases associated with hypercalcemia.
-
Vitamin D intoxication
-
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; 3.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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu hospital, Shandong University | Jinan | Shandong | China | 250012 |
Sponsors and Collaborators
- Shandong University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ITP-Vitamin D+HD-DXM