Clinical Trials Directory

Trials / Completed

CompletedNCT06509581

Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelation Regimen

Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelators

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
180 (actual)
Sponsor
Ain Shams University · Academic / Other
Sex
All
Age
6 Years – 18 Years
Healthy volunteers
Not accepted

Summary

repeated transfusions are the mainstay of disease management in most patients with transfusion dependent beta thalassemia.iron 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.

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 : desferoxamine,deferiprone and deferasirox in moderately iron overloaded children and adolescents with transfusion dependent beta thalassemia and its relation to iron overload over one year.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTvitamin EVitamin E will be taken for 12 months for beta thalassemia patiens on regular packed red blood cell transfusion and chelators(desferoxamine,deferiprone and deferasirox )
OTHERPLACEBOplacebo will be taken for 12 months for beta thalassemia patiens on regular packed red blood cell transfusion and chelators(desferoxamine,deferiprone and deferasirox )

Timeline

Start date
2021-07-05
Primary completion
2022-09-11
Completion
2022-10-11
First posted
2024-07-19
Last updated
2024-07-19

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06509581. Inclusion in this directory is not an endorsement.