NAC Effect on Iron Overload and Blood Transfusion in β-thalassemia Major

NCT05777733 | Unknown Phase 1

• 1 other identifier: NAC as antioxidant
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The effect of N\_acetylcystein as an antioxidant on iron overload and frequency of blood transfusion in β-thalassemia major patients at Assiut Childern Hospital University And its cosubmitted for partial fulfillment of master degree in Pediatrics

Conditions

Thalassemia Major

Keywords

N_acetylcystein antioxidant effect

Outcome Measures

Primary Outcomes (1)

• Serum ferritin level

  Measuring serum ferritin level (mg/dl) before and after 6 months of acetylcystein administration.

  6 months from the baseline

Study Arms (1)

N_acetylcystein as antioxidant on iron and frequency of blood transfusion in thalassemia major

EXPERIMENTAL

N\_acetylcystein administration on single oral dose 10mg /kg for 6 months and it's effect on iron and frequency of blood transfusion before and after its use.

Drug: n-acetylcystine

Interventions

n-acetylcystine DRUG

Single daily oral administration of N\_acetylcystein on dose 10mg /kg/day

Also known as: acetylcystein

N_acetylcystein as antioxidant on iron and frequency of blood transfusion in thalassemia major

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• thalassemia major children .
• On oral iron chelation .

You may not qualify if:

• change in the dose of iron chelation within 3 months before enrollement or during study period .
• Liver impairment
• Renal impairment
• patients not adeherent to therapy

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Mohamed YA, Meabed MH, Ashraf A, Morgan DS, Abdul Latif MG, Abd-Elkareem RM, Ahmed HM. WITHDRAWN:Randomized controlled trial of effect of N-acetylcysteine as an antioxidant on iron overload in children with thalassemia major. Clin Exp Pediatr. 2020 Nov 3. doi: 10.3345/cep.2020.00227. Online ahead of print.

  PMID: 33147909 BACKGROUND

MeSH Terms

Conditions

beta-Thalassemia

Interventions

N-monoacetylcystine

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: N-acetylcystein in dose 10mg /kg single oral dose will be given for 6 months

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: March 21, 2023
• Study Start: March 23, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: August 23, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share