Connection Between Vitamin D Level and the Efficacy of Dexamethasone in Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

A Prospective Observational Study: Connection Between Vitamin D Level and the Efficacy of Dexamethasone in Immune Thrombocytopenia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04320225
• Other study ID #: ITP-vitamin D(observational)
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: September 2020
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The project was undertaking by Qilu Hospital of Shandong University in China. The objective is to find out if there is a connection between vitamin D level and the efficacy of dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Description:

The investigators anticipate to undertaking a prospective, observational，non-randomized control trial of 60 ITP adult patients. Dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days) will be used in the target patients. Vitamin D level will be detected before the utilization of treatment measures. Depend on the vitamin D level, the patients will be divided into 2 groups(higher vitamin D level group and lower vitamin D level group).Platelet count, bleeding and other symptoms were evaluated before and after treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

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; 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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Dexamethasone
HD-DXM (orally at 40 mg daily for 4d )

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained response to ITP treatments	Percentage of patients maintaining PLT count over 30*10^9/L without bleeding	3 months after treatment started