Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia

NCT ID: NCT01763658

Last Updated: 2013-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-09-30

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antioxidant, 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.

Group Type: EXPERIMENTAL

Antox tablets(Mepaco)

Intervention Type: DRUG

effect of antioxidant on disease outcome

drug therapy for ITP

Intervention Type: OTHER

drugs will be selected according to ASH,2011 guidelines

drug therapy for ITP

drug therapy for ITP according to ASH, 2011 guidelines.

Group Type: ACTIVE_COMPARATOR

drug therapy for ITP

Intervention Type: OTHER

drugs will be selected according to ASH,2011 guidelines

Interventions

Antox tablets(Mepaco)

effect of antioxidant on disease outcome

Intervention Type: DRUG

drug therapy for ITP

drugs will be selected according to ASH,2011 guidelines

Intervention Type: OTHER

Other Intervention Names

antioxidant drug; dexamethasone; prednisolone; solumedrol; Anti-D; intravenous immunoglobulin; romioplastin

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohsen Saleh Elalfy

professor of pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohsen S Elalfy, professor

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt

Cairo, , Egypt

Countries

Egypt

Central Contacts

yasmine I Elhenawy, lecturer

Role: CONTACT

dr_yasmi@yahoo.com

0104084038

Facility Contacts

Mohsen Saleh Elalfy, professor

Role: primary

Other Identifiers

Antioxident in ITP

Identifier Type: -

Identifier Source: org_study_id