Back to resultsThe Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
Primary Purpose
Thalassemia Major
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
N-acetyl cysteine
Sponsored by
About this trial
This is an interventional treatment trial for Thalassemia Major
Eligibility Criteria
Inclusion Criteria:
- Thalassemia major children on regular blood transfusion and iron chelation therapy
Exclusion Criteria:
- Renal or hepatic impairments
- Complicated thalassemia major
- Non adherence to therapy or follow up visits
- Change in the iron chelation dose within 3 months before enrollment or during study period
Sites / Locations
- Heba Mostafa Ahmed
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
N-acetylcysteine group
Non n-acetylcysteine group
Arm Description
Patients received oral n-acetylcysteine syrup on dose of 10 mg/kg/day as single dose for 3 months
Thalassemia major patients on regular chelation therapy who didn't receive n-acetylcysteine and served as controls
Outcomes
Primary Outcome Measures
Oxidative stress index (pg/mmol)
Oxidative stress index is calculated as the ratio of total oxidative status (pg/dl) to total anti oxidative capacity (mmol/dl)
Serum ferritin level ( mg/dl)
Secondary Outcome Measures
Full Information
NCT ID
NCT04260516
First Posted
February 4, 2020
Last Updated
February 6, 2020
Sponsor
Beni-Suef University
1. Study Identification
Unique Protocol Identification Number
NCT04260516
Brief Title
The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
Official Title
The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
December 3, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The effect of N-acetylcysteine as antioxidant and its effect on pretransfusion hemoglobin and iron overload in patients with thalassemia were compared to patients who didn't receive n-acetylcysteine after 3 months of study duration
Detailed Description
N-acetylcysteine( NAC) is a widely used mucolytic drug and several studies had reported its efficacy as anti oxidant. Patients with thalassemia major are at great risk for oxidative stress due to excess of b-globin chains and iron overload. In this study the investigators compared the effect of NAC on oxidative status , pretransfusion hemoglobin levels and iron overload in thalassemia patients before and after treatment with NAC for 3 months and with that of patients who served as controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thalassemia Major
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Two groups are followed up for study parameters for 3 months one group is the intervention group and the other is the control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-acetylcysteine group
Arm Type
Active Comparator
Arm Description
Patients received oral n-acetylcysteine syrup on dose of 10 mg/kg/day as single dose for 3 months
Arm Title
Non n-acetylcysteine group
Arm Type
No Intervention
Arm Description
Thalassemia major patients on regular chelation therapy who didn't receive n-acetylcysteine and served as controls
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Intervention Description
Mucolytic and antioxidant drug
Primary Outcome Measure Information:
Title
Oxidative stress index (pg/mmol)
Description
Oxidative stress index is calculated as the ratio of total oxidative status (pg/dl) to total anti oxidative capacity (mmol/dl)
Time Frame
3 months
Title
Serum ferritin level ( mg/dl)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Thalassemia major children on regular blood transfusion and iron chelation therapy
Exclusion Criteria:
Renal or hepatic impairments
Complicated thalassemia major
Non adherence to therapy or follow up visits
Change in the iron chelation dose within 3 months before enrollment or during study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba M Ahmed
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heba Mostafa Ahmed
City
Banī Suwayf
State/Province
Beni Suef
ZIP/Postal Code
62115
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25222041
Citation
Ozdemir ZC, Koc A, Aycicek A, Kocyigit A. N-Acetylcysteine supplementation reduces oxidative stress and DNA damage in children with beta-thalassemia. Hemoglobin. 2014;38(5):359-64. doi: 10.3109/03630269.2014.951890. Epub 2014 Sep 15.
Results Reference
result
Learn more about this trial
The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
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