Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia

NCT07157722 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 9250572
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is to investigate the potential roles of N-acetyl cysteine and Alpha-lipoic acid in patients with beta-thalassemia.

Conditions

Beta Thalassemia

Keywords

NAC; ALA

Outcome Measures

Primary Outcomes (1)

• The change from baseline in carotid intima media thickness (CIMT)

  Non-invasive imaging technique, such as carotid ultrasonography will be used to measure carotid intima media thickness

  3 months

Secondary Outcomes (4)

• Change in Malondialdehyde (MDA)

  3 months

• Change in high sensitivity C-reactive protein (hs-CRP)

  3 months

• Change in asymmetric dimethyl arginine (ADMA)

  3 months

• Change in lipid profile

  3 months

Study Arms (3)

Group 1: (Iron chelating agent group)

ACTIVE COMPARATOR

Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only.

Drug: Iron chelating intervention

Group 2: (Iron chelating agent + NAC group)

ACTIVE COMPARATOR

Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for 12 weeks.

Drug: Iron chelating intervention; Drug: N Acetyl cysteine 600mg

Group 3: (Iron chelating agent + ALA group)

ACTIVE COMPARATOR

Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for 12 weeks.

Drug: Iron chelating intervention; Drug: Alpha Lipoic Acid 600 MG Oral Tablets

Interventions

Iron chelating intervention DRUG

JADENU is indicated for the treatment of chronic iron overload due to blood transfusions.

Group 1: (Iron chelating agent group); Group 2: (Iron chelating agent + NAC group); Group 3: (Iron chelating agent + ALA group)

N Acetyl cysteine 600mg DRUG

N-acetyl cysteine (NAC) 600 mg will be administered orally once daily for 12 weeks.

Group 2: (Iron chelating agent + NAC group)

Alpha Lipoic Acid 600 MG Oral Tablets DRUG

Alpha lipoic acid (ALA) 600 mg will be administered orally once daily for 12 weeks.

Group 3: (Iron chelating agent + ALA group)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with beta-thalassemia who will receive conventional thalassemia management.
• Both genders.
• Age ≥ 18 years old.

You may not qualify if:

• Patients with familial hypercholesterolemia or history of premature atherosclerosis.
• Patients with a prior history of significant cardiovascular diseases, such as coronary artery disease, myocardial infarction, or stroke.
• Patients with severe renal dysfunction.
• Patients with severe hepatic dysfunction.
• Patients with diabetes.
• Patients who will be non-compliant with the prescribed therapy.
• Patients with other hemoglobinopathies.
• Pregnant women.
• Obese patients.
• Patients who will receive antioxidant or anti-inflammatory medications.
• Patients with inflammatory diseases, such as Systemic lupus erythematous, rheumatoid arthritis and inflammatory bowel disease.
• Patients with oxidative stress related diseases, such as Alzheimer, Parkinson, COPD and cancer.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Pharmacy - Tanta University

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Acetylcysteine; Thioctic Acid

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; Carboxylic Acids; Thiophenes; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Sahar M El-Haggar, Professor

  Tanta University

  STUDY DIRECTOR

• Tarek M Mostafa, Professor

  Tanta University

  STUDY DIRECTOR

• Basma A Mansour, Lecturer

  Faculty of Medicine - Mansoura University

  STUDY DIRECTOR

• Mohammed A El hawary, Assistant Professor

  Faculty of Medicine - Mansoura University

  PRINCIPAL INVESTIGATOR

• Mahmoud M Elkholy, Teaching Assistant

  Tanta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud M Elkholy, Master

CONTACT

01023997742; mahmoud.m_elkholy@yahoo.com

Basma A Mansour, PhD

CONTACT

01224445455; basma.atef@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: This is a randomized, parallel, clinical study that will be conducted on 66 patients with beta-thalassemia who fulfill the selection criteria and will be classified randomly into 3 groups as follows: Group I (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only. Group II (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for three months. Group III (n = 22): This group will include twenty-two patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for three months.

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: August 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)