Evaluating the Effect of N-Acetyl Cysteine and Alpha Lipoic Acid in Patients With Beta Thalassemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Iron chelating intervention, N Acetyl cysteine 600mg, Alpha Lipoic Acid 600 MG Oral Tablets.
- Who it may be relevant to
- Registry conditions: Beta Thalassemia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Potential Role of N-Acetyl Cysteine or Alpha-Lipoic Acid as Adjuvant Therapies in the Treatment of Patients With Beta Thalassemia
Overview
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.
Interventions
- Drug Iron chelating intervention
JADENU is indicated for the treatment of chronic iron overload due to blood transfusions. - Drug N Acetyl cysteine 600mg
N-acetyl cysteine (NAC) 600 mg will be administered orally once daily for 12 weeks. - Drug Alpha Lipoic Acid 600 MG Oral Tablets
Alpha lipoic acid (ALA) 600 mg will be administered orally once daily for 12 weeks.
Primary outcome measures
- The change from baseline in carotid intima media thickness (CIMT) [Time frame: 3 months]
Secondary outcome measures (4)
- Change in Malondialdehyde (MDA) [Time frame: 3 months]
- Change in high sensitivity C-reactive protein (hs-CRP) [Time frame: 3 months]
- Change in asymmetric dimethyl arginine (ADMA) [Time frame: 3 months]
- Change in lipid profile [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Pharmacy - Tanta University — Tanta
Identifiers
NCT: NCT07157722 · 9250572