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

Phase 1

Completed

• Conditions: Thalassemia Major
• Interventions: Drug: N-acetyl cysteine

• Registration Number: NCT04260516
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Study Start: 2019-06-03
• Primary Completion: 2019-12-03
• Study Completion: 2019-12-30
• Status Verified: 2020-02
• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-06
• Last Update Submitted: 2020-02-06
• Study First Posted: 2020-02-07
• Last Update Posted: 2020-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Thalassemia major children on regular blood transfusion and iron chelation therapy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-acetylcysteine group	N-acetyl cysteine	Patients received oral n-acetylcysteine syrup on dose of 10 mg/kg/day as single dose for 3 months

Primary Outcome Measures

Name	Time	Method
Serum ferritin level ( mg/dl)	3 months
Oxidative stress index (pg/mmol)	3 months	Oxidative stress index is calculated as the ratio of total oxidative status (pg/dl) to total anti oxidative capacity (mmol/dl)

Trial Locations

Locations (1)

Heba Mostafa Ahmed; 🇪🇬 Banī Suwayf, Beni Suef, Egypt