Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

— ITP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01763658
• Other study ID #: Antioxident in ITP
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: January 6, 2013
• Last updated: January 8, 2013
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: January 2013
• Source: Ain Shams University
• Contact: yasmine I Elhenawy, lecturer
• Phone: 0104084038
• Email: dr_yasmi[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• Antox tablets(Mepaco)
effect of antioxidant on disease outcome

Other:
• drug therapy for ITP
drugs will be selected according to ASH,2011 guidelines

Locations

Country	Name	City	State
Egypt	hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxidant status in ITP	oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)	6 month	Yes
Secondary	antioxidant therapy	antioxidant therapy on bleeding score, platelet count and antioxidant status	6 months	Yes