Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the efficacy of antioxidant cocktails on the alleviation of oxidative stress and iron overload in beta-thalassemia/Hb E patients.

Detailed Description
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60 cases of beta-thalassemia/Hb E patients. All patients will be diagnosed with hemoglobin typing of beta-thalassemia/Hb E disease and not receive blood transfusion or any treatment at least 3 months prior study. The study will be randomized controlled trial that designed before and after treatment with antioxidant cocktail. The antioxidant cocktail consists of vitamin E 400 IU/day, curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day. All patients will receive antioxidant cocktail daily for 12 months. The patients will be regularly followed up and analyzed biochemical parameters every two months during treatment and after withdrawal for 3 months.

Official Title
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Effect of Antioxidant Cocktail in Beta-thalassemia/Hb E Patients

Conditions
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Thalassemia

Intervention / Treatment
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* Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E
* Drug: Curcuminoids and alpha-tocopherol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18-50 years hemoglobin level between 6-9 g/dL during screen visit WHO performance status grade 0-2 signed in informed consents prior to the study entry. Exclusion Criteria: receiving iron chelator and blood transfusion. pregnancy or breastfeeding receiving other drugs except folic acid at least 30 days before study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcuminoids<br>The administrate curcuminoids is intervention for 30 patients | Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E<br>* receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day<br>* Other names: vitamin E 400 IU/day brand name Natural;Drug: Curcuminoids and alpha-tocopherol<br>* group 1: receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day group 2: receiving vitamin E 400 IU/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day<br>|
| Experimental: Vitamin E<br>The vitamin E is intervention for 30 patients | Drug: curcuminoids, N-acetylcysteine, deferiprone and vitamin E<br>* receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day<br>* Other names: vitamin E 400 IU/day brand name Natural;Drug: Curcuminoids and alpha-tocopherol<br>* group 1: receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day group 2: receiving vitamin E 400 IU/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malonyldiadehyde (MDA) | Lipid peroxidation will be assayed by measuring the formation of malonyldialdehyde (MDA). The formation of MDA on red blood cell will be exposed by hydrogen peroxide. Then, MDA will be extracted by trichloroacetic acid (TCA) and will be reacted with thiobarbituric acid (TBA) in boiling condition to MDA-TBAR complex. This complex will be given pink color and measuring at 532 and 600 nm | 1 year after treatment with antioxidant cocktail. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thalassemia, Oxidative stress, antioxidant cocktail