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

NCT04260516 | Completed Phase 1 DMC

• 1 other identifier: FM-BSU REC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Thalassemia Major

Outcome Measures

Primary Outcomes (2)

• 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)

  3 months

• Serum ferritin level ( mg/dl)

  3 months

Study Arms (2)

N-acetylcysteine group

ACTIVE COMPARATOR

Patients received oral n-acetylcysteine syrup on dose of 10 mg/kg/day as single dose for 3 months

Drug: N-acetyl cysteine

Non n-acetylcysteine group

NO INTERVENTION

Thalassemia major patients on regular chelation therapy who didn't receive n-acetylcysteine and served as controls

Interventions

N-acetyl cysteine DRUG

Mucolytic and antioxidant drug

N-acetylcysteine group

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Thalassemia major children on regular blood transfusion and iron chelation therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Heba Mostafa Ahmed

Banī Suwayf, Beni Suweif Governorate, 62115, Egypt

Location

Related Publications (1)

• 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.

  PMID: 25222041 RESULT

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Heba M Ahmed

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Two groups are followed up for study parameters for 3 months one group is the intervention group and the other is the control group

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 7, 2020
• Study Start: June 3, 2019
• Primary Completion: December 3, 2019
• Study Completion: December 30, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)