Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia (ITP)

Ain Shams University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Immune Thrombocytopenia

Treatments: Other: drug therapy for ITP; Drug: Antox tablets(Mepaco)

Study type: Interventional

Funder types: Other

Identifiers

NCT01763658

Antioxident in ITP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Antioxidant, drug therapy for ITP

Experimental group

Description:

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.

Treatment:

Drug: Antox tablets(Mepaco)

Other: drug therapy for ITP

drug therapy for ITP

Active Comparator group

Description:

drug therapy for ITP according to ASH, 2011 guidelines.

Treatment:

Other: drug therapy for ITP