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

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ClinicalTrials.gov Identifier: NCT01763658
Recruitment Status : Unknown
Verified January 2013 by Mohsen Saleh Elalfy, Ain Shams University.
Recruitment status was:  Not yet recruiting
First Posted : January 9, 2013
Last Update Posted : January 9, 2013
Sponsor:
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Antox tablets(Mepaco) Other: drug therapy for ITP Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Oxidant Status in Patients With Immune Thrombocytopenia (ITP) and the Role of an Adjuvant Antioxidant Therapy
Study Start Date : March 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arms and Interventions
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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.
 Drug: Antox tablets(Mepaco)
effect of antioxidant on disease outcome
Other Name: antioxidant drug

Other: drug therapy for ITP
drugs will be selected according to ASH,2011 guidelines
Other Names:
  • dexamethasone
  • prednisolone
  • solumedrol
  • Anti-D
  • intravenous immunoglobulin
  • romioplastin
Active Comparator: drug therapy for ITP
drug therapy for ITP according to ASH, 2011 guidelines.
 Other: drug therapy for ITP
drugs will be selected according to ASH,2011 guidelines
Other Names:
  • dexamethasone
  • prednisolone
  • solumedrol
  • Anti-D
  • intravenous immunoglobulin
  • romioplastin


Outcome Measures
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Primary Outcome Measures :
  1. oxidant status in ITP [ Time Frame: 6 month ]
    oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)


Secondary Outcome Measures :
  1. antioxidant therapy [ Time Frame: 6 months ]
    antioxidant therapy on bleeding score, platelet count and antioxidant status


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01763658


Contacts
Contact: yasmine I Elhenawy, lecturer 0104084038 dr_yasmi@yahoo.com

Locations
Egypt
hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt Not yet recruiting
Cairo, Egypt
Contact: Mohsen Saleh Elalfy, professor         
Principal Investigator: Mohsen Saleh Elalfy, professor         
Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: Mohsen S Elalfy, professor Ain Shams University
More Information
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Responsible Party: Mohsen Saleh Elalfy, professor of pediatrics, Ain Shams University
ClinicalTrials.gov Identifier: NCT01763658     History of Changes
Other Study ID Numbers: Antioxident in ITP
First Posted: January 9, 2013    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: January 2013

Keywords provided by Mohsen Saleh Elalfy, Ain Shams University:
ITP, antioxidant therapy, oxidant status

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
 Pathologic Processes
Skin Manifestations
Signs and Symptoms
Immunoglobulins
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Antioxidants
Immunologic Factors
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Protective Agents