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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01763658
First received: January 6, 2013
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Immune Thrombocytopenia
Drug: Antox tablets(Mepaco)
Other: drug therapy for ITP
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

Primary Outcome Measures:
  • oxidant status in ITP [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
    oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)


Secondary Outcome Measures:
  • antioxidant therapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    antioxidant therapy on bleeding score, platelet count and antioxidant status


Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 6, 2013
Last Updated: January 8, 2013
Health Authority: Egypt: Institutional Review Board

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

Additional relevant MeSH terms:
Antioxidants
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 19, 2014