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

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).

Study Overview

• Status: Unknown
• Conditions: Immune Thrombocytopenia
• Intervention / Treatment: Drug: Rocaltrol; Drug: Dexamethasone

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital, Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Calcitriol Soft Capsules
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: Calcitriol Soft Capsules; Drug: Dexamethasone; HD-DXM (orally at 40 mg daily for 4d )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained response to ITP treatments	Percentage of patients maintaining PLT count over 30*10^9 without bleeding	3 months after treatment started

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of platelet response	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.	3 months after treatment started

Collaborators and Investigators

• Sponsor: Shandong University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Micronutrients; Membrane Transport Modulators; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vasoconstrictor Agents; Calcium Channel Agonists; Dexamethasone; Calcitriol
• Other Study ID Numbers: ITP-Vitamin D+HD-DXM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No