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Completed

NCT Number: NCT04260516

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

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

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Key information

Conditions

Thalassemia Major Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia beta-Thalassemia

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Heba Mostafa Ahmed

Banī Suwayf, Beni Suweif Governorate, 62115, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetyl cysteine

Drug

Mucolytic and antioxidant drug

Primary outcomes

  1. Oxidative stress index (pg/mmol)

    Time frame: 3 months

    Oxidative stress index is calculated as the ratio of total oxidative status (pg/dl) to total anti oxidative capacity (mmol/dl)

  2. Serum ferritin level ( mg/dl)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 7, 2020
Registry last updated
Feb 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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