NAC Effect on Iron Overload and Blood Transfusion in β-thalassemia Major
The Effect of N_acetylcystein as an Antioxidant on Iron Overload and Frequency of Blood Transfusion in β-thalassemia Major Patients at Assiut Childern Hospital University
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- thalassemia major children .
- On oral iron chelation .
Exclusion Criteria:
- change in the dose of iron chelation within 3 months before enrollement or during study period .
- Liver impairment
- Renal impairment
- patients not adeherent to therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: N_acetylcystein as antioxidant on iron and frequency of blood transfusion in thalassemia major
N_acetylcystein administration on single oral dose 10mg /kg for 6 months and it's effect on iron and frequency of blood transfusion before and after its use.
|
Single daily oral administration of N_acetylcystein on dose 10mg /kg/day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum ferritin level
Time Frame: 6 months from the baseline
|
Measuring serum ferritin level (mg/dl) before and after 6 months of acetylcystein administration.
|
6 months from the baseline
|
Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Hematologic Diseases
- Genetic Diseases, Inborn
- Anemia
- Iron Metabolism Disorders
- Anemia, Hemolytic, Congenital
- Anemia, Hemolytic
- Hemoglobinopathies
- Iron Overload
- Thalassemia
- beta-Thalassemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
Other Study ID Numbers
- NAC as antioxidant
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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