- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01763658
Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia (ITP)
Evaluation of Oxidant Status in Patients With Immune Thrombocytopenia (ITP) and the Role of an Adjuvant Antioxidant Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: yasmine I Elhenawy, lecturer
- Phone Number: 0104084038
- Email: dr_yasmi@yahoo.com
Study Locations
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Cairo, Egypt
- hematology clinic ,pediatrics hospital, Ain Shams University hospital Cairo, Egypt
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Contact:
- Mohsen Saleh Elalfy, professor
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Principal Investigator:
- Mohsen Saleh Elalfy, professor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
Study Plan
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.
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effect of antioxidant on disease outcome
Other Names:
drugs will be selected according to ASH,2011 guidelines
Other Names:
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Active Comparator: drug therapy for ITP
drug therapy for ITP according to ASH, 2011 guidelines.
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drugs will be selected according to ASH,2011 guidelines
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oxidant status in ITP
Time Frame: 6 month
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oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)
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6 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
antioxidant therapy
Time Frame: 6 months
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antioxidant therapy on bleeding score, platelet count and antioxidant status
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6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Dexamethasone
- Prednisolone
- Methylprednisolone Hemisuccinate
- Immunoglobulins
- Immunoglobulins, Intravenous
- Antioxidants
- gamma-Globulins
- Rho(D) Immune Globulin
Other Study ID Numbers
- Antioxident in ITP
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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