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

Beni-Suef University100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Thalassemia Major

Interventions

N-acetyl cysteineDRUG

Mucolytic and antioxidant drug

Eligibility

Sex: ALLMin age: 3 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Heba Mostafa Ahmed

Banī Suwayf, Beni Suweif Governorate, Egypt

Outcomes

Primary Outcomes

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)

Time frame: 3 months

Serum ferritin level ( mg/dl)

Time frame: 3 months

Data from ClinicalTrials.gov

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