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

A Multicenter Randomized Open-label Clinical Trial of Vitamin D Combined With HD-DXM Versus HD-DXM for the Treatment of ITP

Sponsors

Lead Sponsor: Shandong University

Source 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.

Overall Status Not yet recruiting
Start Date October 1, 2020
Completion Date October 1, 2021
Primary Completion Date March 1, 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Sustained response to ITP treatments 3 months after treatment started
Secondary Outcome
Measure Time Frame
Evaluation of platelet response 3 months after treatment started
Enrollment 60
Condition
Intervention

Intervention Type: Drug

Intervention Name: Rocaltrol

Description: Rocaltrol 0.25 μg daily for 1 month; HD-DXM (orally at 40 mg daily for 4d )

Other Name: Calcitriol Soft Capsules

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: HD-DXM (orally at 40 mg daily for 4d )

Arm Group Label: Rocaltrol Combining HD-DXM

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Contact

Last Name: Ming Hou, MD,PhD

Phone: +86-531-82169114

Phone Ext.: 9879

Email: [email protected]

Location
Facility: Qilu hospital, Shandong University
Location Countries

China

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Shandong University

Investigator Full Name: Ming Hou

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Rocaltrol Combining HD-DXM

Type: Active Comparator

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

Label: HD-DXM

Type: Active Comparator

Description: HD-DXM (orally at 40 mg daily for 4d )

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov