A study to assess the effect of vitamin D deficiency correction on platelet counts in immune thrombocytopenia patients.

Not Applicable

Completed

• Conditions: Health Condition 1: D693- Immune thrombocytopenic purpura

• Registration Number: CTRI/2017/06/008751
• Lead Sponsor: JIPMER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-12-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 101

Inclusion Criteria

Group A

Newly diagnosed patients (age more than or equal to 13years) of ITP (diagnosed within 1 month of enrolment for present study)

Group B

Patients (age more than or equal to 13 years) already diagnosed to be having ITP (diagnosed for >1 month before enrollment to present study) and with platelet count between 20000-50000/µl on stable/decreasing dose of steroids/immunosuppressants/immunomodulators.

Exclusion Criteria

Group A and Group B

(i) Cases of Evanâ??s syndrome

(ii) Cases of SLE, HCV infection (secondary

ITP cases)

(iii) Those patients who have already received replacement doses of vitamin D before enrolment

into the study

(iv) Patients who are having already diagnosed

malabsorption syndrome, chronic kidney

disease.

(v) Patients who are on antiepileptics before

enrolling into the study.

In addition to these those patients having mucosal bleeds and severe cutaneous bleeds(Extensive ecchymoses) will be excluded in group B

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response : <br/ ><br>For patients with platelet count 20,000/µl, response will be platelet count more than or equal to 20,000/µl or a greater than 2-times the baseline platelet count, whichever is higher and with absence of spontaneous bleeding episodes. <br/ ><br>For patients with platelet count 20,000 to 50,000/µl response will be platelet count more than or equal to 50,000/µl or a greater than 2- times the baseline platelet count, whichever is higher and with absence of spontaneous bleeding episodesTimepoint: 5 weeks

Secondary Outcome Measures

Name	Time	Method
To assess the prevalence of vitamin D deficiency in newly diagnosed immune thrombocytopenia patients (In group A) <br/ ><br>Timepoint: During enrollment into the study <br/ ><br>(Using group A)