Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia (ITP)
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| ClinicalTrials.gov Identifier: NCT01763658 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Immune Thrombocytopenia | Drug: Antox tablets(Mepaco) Other: drug therapy for ITP | Phase 2 Phase 3 |
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 (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 |
| Arm | Intervention/treatment |
|---|---|
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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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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:
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Active Comparator: drug therapy for ITP
drug therapy for ITP according to ASH, 2011 guidelines.
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Other: drug therapy for ITP
drugs will be selected according to ASH,2011 guidelines
Other Names:
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- oxidant status in ITP [ Time Frame: 6 month ]oxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)
- antioxidant therapy [ Time Frame: 6 months ]antioxidant therapy on bleeding score, platelet count and antioxidant status
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| Ages Eligible for Study: | 1 Year to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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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
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
| Contact: yasmine I Elhenawy, lecturer | 0104084038 | dr_yasmi@yahoo.com |
| 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 | |
| Principal Investigator: | Mohsen S Elalfy, professor | Ain Shams University |
| 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:
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ITP, antioxidant therapy, oxidant status |
Additional relevant MeSH terms:
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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 |