The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell Membrane Beta-thalassemia Major
- Conditions
- Beta Thalassemia Major AnemiaHemolysisOxidative Stress
- Interventions
- Drug: Placebo oral tablet
- Registration Number
- NCT03948737
- Lead Sponsor
- Indonesia University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- received frequent transfusions,
- iron chelation
- aged 5 - 18-year-olds
- with no other hematologic disorders
- does not consume any other antioxidants or herbal supplements
- the acute or chronic infection including hepatitis B or hepatitis C,
- splenectomy
- liver failure
- abnormality level of lipid test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alpha-Tocopgerol Alpha-Tocopherol 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. Alpha-Tocopgerol Placebo oral tablet 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. Control Placebo oral tablet Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation. Control Alpha-Tocopherol Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation.
- Primary Outcome Measures
Name Time Method The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major 4 weeks The plasma haptoglobin and hemolysis as hemolysis marker on alpha-tocopherol treatment were assessed by ELISA using Haptoglobin and Hemopexin kit for human
- Secondary Outcome Measures
Name Time Method The effects of α-tocopherol in oxidative stress marker on the red cell membrane of β-thalassemia major 4 weeks The malondialdehyde plasma level as oxidative stress marker on alpha-tocopherol treatment was assessed by Spectrophotometry using TBARS method.
The effects of α-tocopherol in endogenous antioxidant on the red cell membrane of β-thalassemia major 4 weeks The Glutathione as endogenous antioxidant marker on alpha-tocopherol treatment was assessed by ELISA method by using GT40 for Glutathione kit
Trial Locations
- Locations (1)
Thalassemia Centre Kiara RSUP Dr.CiptoMangunkusumo
🇮🇩Jakarta Pusat, Jakarta, Indonesia