Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia (NAC/ALA)

Tanta University

Status and phase: Not yet enrolling; Phase 3

Conditions: Beta Thalassemia

Treatments: Drug: Alpha Lipoic Acid 600 MG Oral Tablets; Drug: Iron chelating intervention; Drug: N Acetyl cysteine 600mg

Study type: Interventional

Funder types: Other

Identifiers

NCT07157722

9250572

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

66 participants in 3 patient groups

Group 1: (Iron chelating agent group)

Active Comparator group

Description:

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

Treatment:

Drug: Iron chelating intervention

Group 2: (Iron chelating agent + NAC group)

Active Comparator group

Description:

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

Treatment:

Drug: N Acetyl cysteine 600mg

Drug: Iron chelating intervention

Group 3: (Iron chelating agent + ALA group)

Active Comparator group

Description:

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

Treatment:

Drug: Iron chelating intervention

Drug: Alpha Lipoic Acid 600 MG Oral Tablets