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

Primary Purpose

Immune Thrombocytopenia

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Antox tablets(Mepaco)
drug therapy for ITP
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring ITP, antioxidant therapy, oxidant status

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antioxidant, drug therapy for ITP

drug therapy for ITP

Arm 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.

drug therapy for ITP according to ASH, 2011 guidelines.

Outcomes

Primary Outcome Measures

oxidant status in ITP
oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)

Secondary Outcome Measures

antioxidant therapy
antioxidant therapy on bleeding score, platelet count and antioxidant status

Full Information

First Posted
January 6, 2013
Last Updated
January 8, 2013
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT01763658
Brief Title
Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia
Acronym
ITP
Official Title
Evaluation of Oxidant Status in Patients With Immune Thrombocytopenia (ITP) and the Role of an Adjuvant Antioxidant Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
ITP, antioxidant therapy, oxidant status

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antioxidant, drug therapy for ITP
Arm Type
Experimental
Arm 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.
Arm Title
drug therapy for ITP
Arm Type
Active Comparator
Arm Description
drug therapy for ITP according to ASH, 2011 guidelines.
Intervention Type
Drug
Intervention Name(s)
Antox tablets(Mepaco)
Other Intervention Name(s)
antioxidant drug
Intervention Description
effect of antioxidant on disease outcome
Intervention Type
Other
Intervention Name(s)
drug therapy for ITP
Other Intervention Name(s)
dexamethasone, prednisolone, solumedrol, Anti-D, intravenous immunoglobulin, romioplastin
Intervention Description
drugs will be selected according to ASH,2011 guidelines
Primary Outcome Measure Information:
Title
oxidant status in ITP
Description
oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)
Time Frame
6 month
Secondary Outcome Measure Information:
Title
antioxidant therapy
Description
antioxidant therapy on bleeding score, platelet count and antioxidant status
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yasmine I Elhenawy, lecturer
Phone
0104084038
Email
dr_yasmi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen S Elalfy, professor
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohsen Saleh Elalfy, professor
First Name & Middle Initial & Last Name & Degree
Mohsen Saleh Elalfy, professor

12. IPD Sharing Statement

Learn more about this trial

Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia

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