Use of Vitamin D as An Adjuvant Treatment in Children With Chronic Idiopathic Thrombocytopenic Purpura
Status:
Not yet recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
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