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

B

Beni-Suef University

Status and phase

Completed
Phase 1

Conditions

Thalassemia Major

Treatments

Drug: N-acetyl cysteine

Study type

Interventional

Funder types

Other

Identifiers

NCT04260516
FM-BSU REC

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

3 to 14 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

N-acetylcysteine group
Active Comparator group
Description:
Patients received oral n-acetylcysteine syrup on dose of 10 mg/kg/day as single dose for 3 months
Treatment:
Drug: N-acetyl cysteine
Non n-acetylcysteine group
No Intervention group
Description:
Thalassemia major patients on regular chelation therapy who didn't receive n-acetylcysteine and served as controls

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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