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

Not Applicable

Completed

• Conditions: Beta-Thalassemia
• Interventions: Dietary Supplement: vitamin E; Other: PLACEBO

• Registration Number: NCT06509581
• Lead Sponsor: Ain Shams University

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 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.

Study Timeline

• Study Start: 2021-07-05
• Primary Completion: 2022-09-11
• Study Completion: 2022-10-11
• Status Verified: 2024-07
• Study First Submitted: 2024-07-06
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beta thalassemia patiens with oxidative stress and taking iron chelators receiving vitamin E	vitamin E	Beta thalassemia patiens with oxidative stress and taking iron chelators(desferoxamine,deferiprone or deferasirox) receiving vitamin E in dose 400 mg daily for 12 months
Beta thalassemia patiens with oxidative stress and taking iron chelators receiving placebo	PLACEBO	B thalassemia patiens with oxidative stress and taking iron chelators(desferoxamine,deferiprone or deferasirox) receiving placebo for 12 months

Primary Outcome Measures

Name	Time	Method
effect of vitamin E on Liver iron concentration (LIC)	12 months	measuring the LIC using MRI (magnetic resonance imaging) in mg/g

Secondary Outcome Measures

Name	Time	Method
effect of vitamin E on antioxidants enzymes	12 months	measuring antioxidants enzymes; * antioxidant enzymes,
effect of vit E supplementation on SF	12 months	measuring serum ferritin(SF)in ng/ml

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Abbasia, Egypt