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Oxidant Status and Effect of Antioxidant in Immune Thrombocytopenia

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01763658
Acronym
ITP
Enrollment
100
Registered
2013-01-09
Start date
2013-03-31
Completion date
2013-09-30
Last updated
2013-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Thrombocytopenia

Keywords

ITP, antioxidant therapy, oxidant status

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.

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.

Interventions

DRUGAntox tablets(Mepaco)

effect of antioxidant on disease outcome

OTHERdrug therapy for ITP

drugs will be selected according to ASH,2011 guidelines

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
oxidant status in ITP6 monthoxidant and antioxidant systems initially in patients with acute and chronic immune thrombocytopenia (ITP)

Secondary

MeasureTime frameDescription
antioxidant therapy6 monthsantioxidant therapy on bleeding score, platelet count and antioxidant status

Countries

Egypt

Contacts

Primary Contactyasmine I Elhenawy, lecturer
dr_yasmi@yahoo.com0104084038

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026