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

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

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).

Study Overview

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

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

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

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed ITP patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lower vitamin D level group; The vitamin D level is lower than 20 nmol/L.	Drug: Dexamethasone; HD-DXM (orally at 40 mg daily for 4d )
Higher vitamin D level group; The vitamin D level is higher than 20 nmol/L.	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/L without bleeding	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: March 21, 2020
• First Submitted That Met QC Criteria: March 21, 2020
• First Posted (ACTUAL): March 24, 2020

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; 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; Dexamethasone
• Other Study ID Numbers: ITP-vitamin D(observational)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No