Status:
COMPLETED
Vitamin E Supplementation for Children With Transfusion Dependent Beta Thalassemia on Different Iron Chelation Regimen
Lead Sponsor:
Ain Shams University
Conditions:
Beta-Thalassemia
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief 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 str...
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 str...
Eligibility Criteria
Inclusion
- Beta thalassemia patients on regular packed red blood cells transfusion,with vitamin E deficiency
- serum ferritin 1000-2500 ug/l
- cardiacT2\*\>10ms and ejection fraction \>55%
Exclusion
- Diabetes,active hepatitis(serum transaminases \>2 times ULN)
- renal impairment (serum creatinine\>2times ULN)
- participation in previous investigational drug study with 3 months preceding screening supplementation with antioxidants or vitamins within 3 months prior to the study and patients with known allergy to vitamin
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06509581
Start Date
July 5 2021
End Date
October 11 2022
Last Update
July 19 2024
Active Locations (1)
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1
Ain Shams University
Cairo, Abbasia, Egypt, 11517