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

NCT06509581 | Completed DMC

• 1 other identifier: MD12/2020
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Beta-Thalassemia

Keywords

thalasssemia; vitamin E; Oxidative stress

Outcome Measures

Primary Outcomes (1)

• effect of vitamin E on Liver iron concentration (LIC)

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

  12 months

Secondary Outcomes (2)

• effect of vitamin E on antioxidants enzymes

  12 months

• effect of vit E supplementation on SF

  12 months

Study Arms (2)

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

EXPERIMENTAL

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

Dietary Supplement: vitamin E

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

PLACEBO COMPARATOR

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

Other: PLACEBO

Interventions

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 )

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

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 )

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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, 11517, Egypt

Location

Related Publications (2)

• Fibach E, Rachmilewitz EA. The role of antioxidants and iron chelators in the treatment of oxidative stress in thalassemia. Ann N Y Acad Sci. 2010 Aug;1202:10-6. doi: 10.1111/j.1749-6632.2010.05577.x.

  PMID: 20712766 BACKGROUND

• ElLaboudy MA, Saber MM, Adly AA, Ismail EA, Ibrahim FA, Elalfy OM. Oxidative stress markers and tissue iron overload after 12-months vitamin E supplementation for children with transfusion-dependent beta-thalassemia on different iron chelators: A randomized placebo-controlled trial. Clin Nutr. 2025 Jul;50:154-163. doi: 10.1016/j.clnu.2025.05.003. Epub 2025 May 14.

  PMID: 40424814 DERIVED

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 19, 2024
• Study Start: July 5, 2021
• Primary Completion: September 11, 2022
• Study Completion: October 11, 2022
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)