A Multicenter Randomized Study of Vitamin D Combined With HD-DXM Versus HD-DXM for the Treatment of ITP

Phase 4

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: Rocaltrol; Drug: Dexamethasone

• Registration Number: NCT04094805
• Lead Sponsor: Shandong University

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).

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 Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09
• Study Start: 2020-10-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Corresponding to the diagnostic criteria for immune thrombocytopenia
2. Newly diagnosed ITP patients
3. To show a platelet count <30 * 10^9/L, and with bleeding manifestations
4. Willing and able to sign written informed consent

Exclusion Criteria

1. Suffered from diseases associated with hypercalcemia.
2. Vitamin D intoxication
3. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit;
4. 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;
5. Current HIV infection;
6. 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)
7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period;
8. 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;
9. Patients who are deemed unsuitable for the study by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocaltrol Combining HD-DXM	Dexamethasone	Rocaltrol 0.25 μg once per day, 1 month; HD-DXM (orally at 40 mg daily for 4d )
HD-DXM	Rocaltrol	HD-DXM (orally at 40 mg daily for 4d )
Rocaltrol Combining HD-DXM	Rocaltrol	Rocaltrol 0.25 μg once per day, 1 month; HD-DXM (orally at 40 mg daily for 4d )

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Qilu hospital, Shandong University; 🇨🇳 Jinan, Shandong, China