Microparticle levels in transfusion-dependent thalassemia patients age more than 10 to 25 years. Microparticles in transfusion-dependent thalassemia, vitamin E in transfusion-dependent thalassemia, TDT, microparticles, vitamin E
Conditions
Interventions
Once daily dose of vitamin E (400IU) given orally for the duration of 24 weeks,Once daily dose of placebo containing water and food coloring given orally for the duration of 24 weeks
Experimental Drug,Placebo Comparator Drug
Vitamin E ,Placebo
Sponsors
Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand
Eligibility
Sex/Gender
All
Age
10 Years to 25 Years
Inclusion criteria
Inclusion criteria: 1. Severe beta-thalassemia, including beta-thalassemia major, beta-thalassemia/HbE , delta-beta-thalassemia, and severe alpha-thalassemia, including HbH with Hb Constant Spring (CS)/Pakse (PS), EF Bart's with Hb CS/PS, AE Bart's with CS/PS, who have followed up at the Hematology Clinic, Department of Pediatrics, Faculty of Medicine Ramathibodi Hospital, Mahidol University 2. Transfusion-dependent (defined as the need of red cell transfusion of at least 7 transfusions/year) 3. Patients and/or guardians informed consents
Exclusion criteria
Exclusion criteria: 1. Not consent 2. History of vitamin E allergy 3. History of allergy to food coloring 4. History of bleeding disorders 5. Necessity of receiving other anti-oxidant agents, such as vitamin C or N-acetylcysteine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numbers of red cell-, platelet- and endothelial-derived microparticles at 24 weeks after vitamin E supplementation Flow cytometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid peroxidation markers, such as malondialdehyde and glutathione peroxidase at 24 weeks after vitamin E supplementation ELISA,Vitamin E level at 24 weeks after vitamin E supplementation High-Performance liquid chromatography,Number of phosphatidyl serine-exposing red cells at 24 weeks after vitamin E supplementation Flow cytometry,Nitric oxide level at 24 weeks after vitamin E supplementation Nitric oxide analyzer,Hemolytic parameters, such as indirect bilirubinemia, reticulocyte count and lactate dehydrogenase at 24 weeks after vitamin E supplementation Routine chemical analysis | — |
Countries
Thailand
Contacts
Public ContactDuantida Songdej
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed