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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260516
Recruitment Status : Completed
First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Heba Mostafa Ahmed, 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

Condition or disease Intervention/treatment Phase
Thalassemia Major Drug: N-acetyl cysteine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups are followed up for study parameters for 3 months one group is the intervention group and the other is the control group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of N-acetylcysteine on Oxidative Stress Status and Iron Overload in Thalassemia Major
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : December 3, 2019
Actual Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia

Arm Intervention/treatment
Active Comparator: N-acetylcysteine group
Patients received oral n-acetylcysteine syrup on dose of 10 mg/kg/day as single dose for 3 months
Drug: N-acetyl cysteine
Mucolytic and antioxidant drug

No Intervention: Non n-acetylcysteine group
Thalassemia major patients on regular chelation therapy who didn't receive n-acetylcysteine and served as controls



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260516


Locations
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Egypt
Heba Mostafa Ahmed
Banī Suwayf, Beni Suef, Egypt, 62115
Sponsors and Collaborators
Beni-Suef University
Investigators
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Principal Investigator: Heba M Ahmed Beni-Suef University

Publications of Results:
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Responsible Party: Heba Mostafa Ahmed, Assistant Professor, Beni-Suef University
ClinicalTrials.gov Identifier: NCT04260516    
Other Study ID Numbers: FM-BSU REC
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes