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

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ClinicalTrials.gov Identifier: NCT04260516

Recruitment Status : Completed

First Posted : February 7, 2020

Last Update Posted : February 7, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Heba Mostafa Ahmed, Beni-Suef University

Study Description

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.

Study Design

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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 Genetics related topics: Beta thalassemia

MedlinePlus related topics: Iron Thalassemia

Drug Information available for: Acetylcysteine

Genetic and Rare Diseases Information Center resources: Thalassemia Beta-thalassemia

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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)
Serum ferritin level ( mg/dl) [ Time Frame: 3 months ]

Eligibility Criteria

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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

Contacts and Locations

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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

More Information

Publications of Results:

Ozdemir ZC, Koc A, Aycicek A, Kocyigit A. N-Acetylcysteine supplementation reduces oxidative stress and DNA damage in children with beta-thalassemia. Hemoglobin. 2014;38(5):359-64. doi: 10.3109/03630269.2014.951890. Epub 2014 Sep 15.

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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

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