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The current study is to investigate the potential roles of N-acetyl cysteine and Alpha-lipoic acid in patients with beta-thalassemia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: (Iron chelating agent group) | Active Comparator | Patients with beta-thalassemia who will receive conventional thalassemia management (iron chelating agent) only. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron chelating intervention | Drug | JADENU is indicated for the treatment of chronic iron overload due to blood transfusions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Malondialdehyde (MDA) | Malondialdehyde (MDA) level will be assessed using commercially available kit | 3 months |
| Change in high sensitivity C-reactive protein (hs-CRP) | High sensitivity C-reactive protein (hs-CRP) level will be assessed using commercially available kit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud M Elkholy, Master | Contact | 01023997742 | mahmoud.m_elkholy@yahoo.com | |
| Basma A Mansour, PhD | Contact | 01224445455 | basma.atef@mans.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Sahar M El-Haggar, Professor | Tanta University | Study Director |
| Tarek M Mostafa, Professor | Tanta University | Study Director |
| Basma A Mansour, Lecturer |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy - Tanta University | Tanta | 31511 | Egypt |
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| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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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.
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| N Acetyl cysteine 600mg | Drug | N-acetyl cysteine (NAC) 600 mg will be administered orally once daily for 12 weeks. |
|
| Alpha Lipoic Acid 600 MG Oral Tablets | Drug | Alpha lipoic acid (ALA) 600 mg will be administered orally once daily for 12 weeks. |
|
| 3 months |
| Change in asymmetric dimethyl arginine (ADMA) | Asymmetric dimethyl arginine (ADMA) level will be assessed using commercially available kit. | 3 months |
| Change in lipid profile | HDL, total cholesterol and triglycerides will be assessed using commercially available kits. | 3 months |
| 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 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002264 | Carboxylic Acids |
| D013876 | Thiophenes |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |