Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia

Study Overview
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Brief Summary
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Oxidative stress occurs as a result of increased activity of free radical-producing enzymes, decreased activity of free radical-removing enzymes, and insufficient levels of antioxidants. The most sensitive molecules to oxidation are lipids. Loss of cell membrane elasticity, increased cell fragility, and a shortened cellular life span results from oxidation of cell membrane lipids.

Detailed Description
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Free oxygen radicals may have an effect on the structural and functional damage of platelets and plays a role in pathogenesis of thrombocytopenia in both, acute and chronic ITP. Selenium is an essential mineral found in small amounts in the body. It works as an antioxidant, especially when combined with other antioxidants as vitamin E , A and C. Antioxidants neutralize free radicals and may reduce or even help prevent some of the damage they cause. aim of this study is to assess oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP) and 6 months later.Another aim of the study is to evaluate effect of antioxidant therapy on bleeding score, platelet count and antioxidant status during 6 months follow-up.

Official Title
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Evaluation of Oxidant Status in Patients With Immune Thrombocytopenia (ITP) and the Role of an Adjuvant Antioxidant Therapy

Conditions
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Immune Thrombocytopenia

Intervention / Treatment
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* Drug: Antox tablets(Mepaco)
* Other: drug therapy for ITP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. All patients less than 18 years with primary ITP; at initial presentation with platelet count less than 40 x 109/L attended Ain Shams Hematology clinic Children hospital from January 2013 and followed-up for 6 months. 2. For acute ITP, patients will be newly diagnosed (about one month within the diagnosis). 3. For chronic (12-24 months) and persistent (3-12 months) ITP patients. Exclusion Criteria: Patients' platelet count more than 40 x 109/L.; or above 18 years Patients with secondary cause for thrombocytopenia. Patients with any there associated chronic illness affecting oxidant status

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antioxidant, drug therapy for ITP<br>interventional arm 1 and will receive antioxidant therapy (Antox tablets ( 1 tablet contains : Vit. A 2000 IU, Vit C 90 mg, Vit E 15 mg and selenium yeast 55 ug ) with the therapy selected for ITP tailored according to patient's presentation.For Antox tablets it will be given daily for 6 months. | Drug: Antox tablets(Mepaco)<br>* effect of antioxidant on disease outcome<br>* Other names: antioxidant drug;Other: drug therapy for ITP<br>* drugs will be selected according to ASH,2011 guidelines<br>* Other names: romioplastin;|
| Active Comparator: drug therapy for ITP<br>drug therapy for ITP according to ASH, 2011 guidelines. | Other: drug therapy for ITP<br>* drugs will be selected according to ASH,2011 guidelines<br>* Other names: romioplastin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidant status in ITP | oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP) | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antioxidant therapy | antioxidant therapy on bleeding score, platelet count and antioxidant status | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ITP, antioxidant therapy, oxidant status