Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia

Phase 2

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: Antox tablets(Mepaco); Other: drug therapy for ITP

• Registration Number: NCT01763658
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2013-01
• Study First Submitted: 2013-01-06
• Study First Submitted QC: 2013-01-08
• Last Update Submitted: 2013-01-08
• Study First Posted: 2013-01-09
• Last Update Posted: 2013-01-09
• Study Start: 2013-03
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

1. Patients' platelet count more than 40 x 109/L.; or above 18 years
2. Patients with secondary cause for thrombocytopenia.
3. Patients with any there associated chronic illness affecting oxidant status

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antioxidant, drug therapy for ITP	Antox tablets(Mepaco)	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.
Antioxidant, drug therapy for ITP	drug therapy for ITP	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 therapy for ITP	drug therapy for ITP	drug therapy for ITP according to ASH, 2011 guidelines.

Primary Outcome Measures

Name	Time	Method
oxidant status in ITP	6 month	oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)

Secondary Outcome Measures

Name	Time	Method
antioxidant therapy	6 months	antioxidant therapy on bleeding score, platelet count and antioxidant status

Trial Locations

Locations (1)

hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt; 🇪🇬 Cairo, Egypt