The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell Membrane Beta-thalassemia Major

Study Overview
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Brief Summary
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The accumulation of unpaired α-globin chains in β-thalassemia major patients may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, has been known as a potent scavenger of lipid radicals in the red cell membrane of β-thalassemia major patient. By this randomized controlled trial, the investigators would like to evaluate the effects of α-tocopherol in hemolysis and oxidative stress on the red cell membrane of β-thalassemia major.

Detailed Description
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Background: The accumulation of unpaired α-globin chains in β-thalassemia major patients may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, has been known as a potent scavenger of lipid radicals in the red cell membrane of β-thalassemia major patients. Purpose: To evaluate the effects of α-tocopherol in hemolysis and oxidative stress on the red cell membrane of β-thalassemia major. Methods: In this randomized controlled trial, the investigators allocated subjects in the placebo and α-tocopherol groups. Doses of α-tocopherol were based on the recommendation of Institute of Medicine: 4-8 years old 200 mg/day; 9-13 years old 400 mg/day; 14-18 years old 600 mg/day. Hemolysis, oxidative stress, and antioxidant variables were evaluated before and after 4 weeks of consuming either α-tocopherol or placebo, performed prior to blood transfusions.

Official Title
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The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell

Conditions
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Beta Thalassemia Major Anemia, Hemolysis, Oxidative Stress

Intervention / Treatment
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* Drug: Alpha-Tocopherol
* Drug: Placebo oral tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: received frequent transfusions, iron chelation aged 5 - 18-year-olds with no other hematologic disorders does not consume any other antioxidants or herbal supplements Exclusion Criteria: the acute or chronic infection including hepatitis B or hepatitis C, splenectomy liver failure abnormality level of lipid test

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Beta thalassemia major children
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alpha-Tocopgerol<br>Alpha-Tocopherol supplementation will be given orally for 4 weeks with doses adjusted by age. 5-8 years old: 200 mg daily, 9-13 years old: 400 mg daily and 14-18 years old 600 mg daily. | Drug: Alpha-Tocopherol<br>* all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.<br>* Other names: Santa E;Drug: Placebo oral tablet<br> <br> * Other names: Alpha-tocopherol placebo;|
| Placebo Comparator: Control<br>Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation. | Drug: Alpha-Tocopherol<br>* all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.<br>* Other names: Santa E;Drug: Placebo oral tablet<br> <br> * Other names: Alpha-tocopherol placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major | The plasma haptoglobin and hemolysis as hemolysis marker on alpha-tocopherol treatment were assessed by ELISA using Haptoglobin and Hemopexin kit for human | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of α-tocopherol in oxidative stress marker on the red cell membrane of β-thalassemia major | The malondialdehyde plasma level as oxidative stress marker on alpha-tocopherol treatment was assessed by Spectrophotometry using TBARS method. | 4 weeks | 
| The effects of α-tocopherol in endogenous antioxidant on the red cell membrane of β-thalassemia major | The Glutathione as endogenous antioxidant marker on alpha-tocopherol treatment was assessed by ELISA method by using GT40 for Glutathione kit | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haptoglobin, Hemopexin, Hemolysis, Malondialdehyde, Glutathione, Oxidative stress, Alpha-Tocopherol