Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509581
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-06
Brief Title:
Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelation Regimen
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelators
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
repeated transfusions are the mainstay of disease management in most patients with transfusion dependent beta thalassemiairon overload predispose to oxidative stress and tissue injury
oxidative stress play important role in pathogenesis of anemia in beta thalassemia
vitamin E is often depleted in thalassemia patients
oxidative stress play important role in pathogenesis of anemia in beta thalassemia
vitamin E is often depleted in thalassemia patients
Detailed Description:
oxidative stress status is very important in thalassemic patients and explains the different manifestations in thalassemic patients
vitamin E is fat soluble vitamin shown to reduce the oxidative stress in thalassemia and to reduce lipid peroxidation of red cell membranes
therefore this study shows the safety of oral vitamin E as adjuvant therapy to three iron chelators desferoxaminedeferiprone and deferasirox in moderately iron overloaded children and adolescents with transfusion dependent beta thalassemia and its relation to iron overload over one year
vitamin E is fat soluble vitamin shown to reduce the oxidative stress in thalassemia and to reduce lipid peroxidation of red cell membranes
therefore this study shows the safety of oral vitamin E as adjuvant therapy to three iron chelators desferoxaminedeferiprone and deferasirox in moderately iron overloaded children and adolescents with transfusion dependent beta thalassemia and its relation to iron overload over one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None