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Completed

NCT Number: NCT06509581

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

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.

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Key information

Conditions

Beta-Thalassemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbasia, 11517, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. effect of vitamin E on Liver iron concentration (LIC)

    Time frame: 12 months

    measuring the LIC using MRI (magnetic resonance imaging) in mg/g

Secondary outcomes

  1. effect of vitamin E on antioxidants enzymes

    Time frame: 12 months

    measuring antioxidants enzymes

    • antioxidant enzymes,

  2. effect of vit E supplementation on SF

    Time frame: 12 months

    measuring serum ferritin(SF)in ng/ml

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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