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

Not Applicable

Not yet recruiting

• Conditions: Beta Thalassemia
• Interventions: Drug: Iron chelating intervention; Drug: N Acetyl cysteine 600mg; Drug: Alpha Lipoic Acid 600 MG Oral Tablets

• Registration Number: NCT07157722
• Lead Sponsor: Tanta University

Brief Summary

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

Detailed Description

Beta-thalassemia (β-thalassemia) is a hereditary blood disorder, which is characterized by a genetic disorder in the production of β-globin chains. β-thalassemia is inherited mainly by an autosomal recessive manner resulting in reduced synthesis or absence of β-globin chains, leading to ineffective erythropoiesis and chronic hemolytic anemia. It is classified according to the severity into major, intermedia and minor.

This is a randomized, parallel, clinical study that will be conducted on sixty-six patients with beta-thalassemia. The study duration will be 12 weeks. Patients will be divided into three 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.

The study will be approved by the Research Ethical Committee at Faculty of Pharmacy, Tanta University. All participants will be informed about benefits and risks of the study. The privacy of all participants will be respected and the data of enrolled participants will be confidential. All participants will sign their written informed consent.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study Start: 2025-08-30
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: (Iron chelating agent group)	Iron chelating intervention	Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only.
Group 2: (Iron chelating agent + NAC group)	Iron chelating intervention	Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for 12 weeks.
Group 2: (Iron chelating agent + NAC group)	N Acetyl cysteine 600mg	Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus NAC (600 mg orally once daily) for 12 weeks.
Group 3: (Iron chelating agent + ALA group)	Alpha Lipoic Acid 600 MG Oral Tablets	Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for 12 weeks.
Group 3: (Iron chelating agent + ALA group)	Iron chelating intervention	Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) plus ALA (600 mg orally once daily) for 12 weeks.

Primary Outcome Measures

Name	Time	Method
The change from baseline in carotid intima media thickness (CIMT)	3 months	Non-invasive imaging technique, such as carotid ultrasonography will be used to measure carotid intima media thickness

Secondary Outcome Measures

Name	Time	Method
Change in Malondialdehyde (MDA)	3 months	Malondialdehyde (MDA) level will be assessed using commercially available kit
Change in high sensitivity C-reactive protein (hs-CRP)	3 months	High sensitivity C-reactive protein (hs-CRP) level will be assessed using commercially available kit.
Change in asymmetric dimethyl arginine (ADMA)	3 months	Asymmetric dimethyl arginine (ADMA) level will be assessed using commercially available kit.
Change in lipid profile	3 months	HDL, total cholesterol and triglycerides will be assessed using commercially available kits.

Trial Locations

Locations (1)

Faculty of Pharmacy - Tanta University; 🇪🇬 Tanta, Egypt