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

January 8, 2013 updated by: Mohsen Saleh Elalfy, Ain Shams University

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

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Cairo, Egypt
        • hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt
        • Contact:
          • Mohsen Saleh Elalfy, professor
        • Principal Investigator:
          • Mohsen Saleh Elalfy, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
effect of antioxidant on disease outcome
Other Names:
  • antioxidant drug
drugs will be selected according to ASH,2011 guidelines
Other Names:
  • prednisolone
  • dexamethasone
  • solumedrol
  • intravenous immunoglobulin
  • Anti-D
  • romioplastin
Active Comparator: drug therapy for ITP
drug therapy for ITP according to ASH, 2011 guidelines.
drugs will be selected according to ASH,2011 guidelines
Other Names:
  • prednisolone
  • dexamethasone
  • solumedrol
  • intravenous immunoglobulin
  • Anti-D
  • romioplastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
oxidant status in ITP
Time Frame: 6 month
oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antioxidant therapy
Time Frame: 6 months
antioxidant therapy on bleeding score, platelet count and antioxidant status
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

January 6, 2013

First Submitted That Met QC Criteria

January 8, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

January 9, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

January 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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