The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major

Thalassemia Major Clinical Trial

Official title:

The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260516
• Other study ID #: FM-BSU REC
• Status: Completed
• Phase: Phase 1
• Start date: June 3, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• beta-Thalassemia
• Iron Overload
• Thalassemia
• Thalassemia Major

Intervention

Drug:
• N-acetyl cysteine
Mucolytic and antioxidant drug

Locations

Country	Name	City	State
Egypt	Heba Mostafa Ahmed	Bani Suwayf	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Ozdemir ZC, Koc A, Aycicek A, Kocyigit A. N-Acetylcysteine supplementation reduces oxidative stress and DNA damage in children with ß-thalassemia. Hemoglobin. 2014;38(5):359-64. doi: 10.3109/03630269.2014.951890. Epub 2014 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months
Primary	Serum ferritin level ( mg/dl)		3 months