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

Ain Shams University

Status: Completed

Conditions: Beta-Thalassemia

Treatments: Dietary Supplement: vitamin E; Other: PLACEBO

Study type: Interventional

Funder types: Other

Identifiers

NCT06509581

MD12/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups, including a placebo group

Beta thalassemia patiens with oxidative stress and taking iron chelators receiving vitamin E

Experimental group

Description:

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

Treatment:

Dietary Supplement: vitamin E

Beta thalassemia patiens with oxidative stress and taking iron chelators receiving placebo

Placebo Comparator group

Description:

B thalassemia patiens with oxidative stress and taking iron chelators(desferoxamine,deferiprone or deferasirox) receiving placebo for 12 months

Treatment:

Other: PLACEBO