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

NCT06073925 | Unknown Early Phase 1 DMC FDA Drug

• 1 other identifier: MS.23.03.2332
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Immune Thrombocytopenia

Keywords

(ITP) Idiopathic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

• Participants who receive vitamin D will show change platelet count more than placepo group

  To evaluate the efficacy of VD supplementation as an adjuvant therapy in chronic ITP children and its effect on platelet count and bleeding score.

  3 month

Study Arms (3)

chronic ITP children with VD level less than 30 ng/ml.

ACTIVE COMPARATOR

will receive VD 3 50000 IU per week for 3 months beside their treatment for ITP.

Drug: VIT D

chronic ITP children with VD level more than 30 ng/ml.

ACTIVE COMPARATOR

will receive VD 3 50000 IU per week for 3 months beside their treatment for ITP.

Drug: VIT D

Placebo

NO INTERVENTION

will receive their treatment for ITP.

Interventions

VIT D DRUG

50000 IU per week of VIT D

Also known as: Navigen

chronic ITP children with VD level less than 30 ng/ml.; chronic ITP children with VD level more than 30 ng/ml.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Chirdren from 1 year to 18 years.
• Diagnosed with Chronic ITP .
• Platelet count \<100,000/microL.

You may not qualify if:

• Other causes of thrombocytopenia.
• Acute and persistant ITP.
• Dysmorphic feature.
• Patients with other comorbidities.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: October 10, 2023
• Study Start: December 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10