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

NCT ID: NCT04094805

Last Updated: 2020-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-10-01

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rocaltrol Combining HD-DXM

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

Group Type: ACTIVE_COMPARATOR

Rocaltrol

Intervention Type: DRUG

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

Dexamethasone

Intervention Type: DRUG

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

HD-DXM

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

Group Type: ACTIVE_COMPARATOR

Rocaltrol

Intervention Type: DRUG

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

Interventions

Rocaltrol

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

Intervention Type: DRUG

Dexamethasone

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

Intervention Type: DRUG

Other Intervention Names

Calcitriol Soft Capsules

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Qilu hospital, Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Ming Hou, MD,PhD

Role: CONTACT

houming@medmail.com.cn

+86-531-82169114 ext. 9879

Other Identifiers

ITP-Vitamin D+HD-DXM

Identifier Type: -

Identifier Source: org_study_id