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Use of Vitamin D as An Adjuvant Treatment in Children With Chronic Idiopathic Thrombocytopenic Purpura

NCT06073925 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-10

No results posted yet for this study

Summary

Immune thrombocytopenia is an autoimmune disease in which platelets are targeted by the host immune system. Platelet depletion occurs when autoantibodies targeting glycoproteins (αIIb-β3 and GPIb) found on the surface of platelets opsonize the cells, resulting in destruction by macrophages. These antibodies can also bind to megakaryocytes and prevent complete maturation, which results in lowered levels of platelet production Vitamin D (VD) or 1,25-dihydroxyvitamin D, may be a potent immunomodulator, and it may have potential therapeutic use in many autoimmune diseases In 1991, researchers found that the production of interleukin (IL)-6 and IL-2 in cell cultures were reduced by 1,25(OH)2D3 VD deficiency is very common in children with either newly diagnosed or chronic ITP form.Correlation between hypovitaminosis D and a higher incidence of infections and autoimmune diseases was reported as well Case-Control interventional study (over time each participant will be randomized to be enrolled in one of either study arms in a random sequence). To evaluate the efficacy of VD supplementation as an adjuvant therapy in chronic ITP children and its effect on platelet count and bleeding score.

The participants will be - Children from 1 year to 18 years diagnosed with Chronic ITP with platelet count \<100,000/microL.

Patients groups will be:

Patients of Chronic ITP aged from 1year till 18 years old . in this study will be divided into 2 groups ● Group A : All patients with VIT D insufficiency(The preferred level for 25(OH)D is now recommended by many experts to be \>30 ng/ml) will receive supplementary Vitamin D3(NIVAGEN Vitamin D3 Cholecalciferol 50000 IU) oral once weekly for 3 months as adjuvant therapy in combination with their treatment for ITP.

● Group B : patients in this group have sufficient VIT D level and will be divided into 2 groups :

* Group 1 B :will receive their standard treatment for ITP with VIT D.
* Group 2 B :will receive their standard treatment for ITP without VIT D. Complete blood picture will be made at the beginning of study then monthly to evaluate the number of platelets that expected to increase after VD supplementation

Conditions

Interventions

DRUG

VIT D

50000 IU per week of VIT D

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-07-31
Completion
2024-10-31
FDA Drug
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06073925 on ClinicalTrials.gov