The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell Membrane Beta-thalassemia Major

University of Indonesia (UI)

Status: Completed

Conditions: Hemolysis; Beta Thalassemia Major Anemia; Oxidative Stress

Treatments: Drug: Placebo oral tablet; Drug: Alpha-Tocopherol

Study type: Interventional

Funder types: Other

Identifiers

NCT03948737

NSovira

Details and patient eligibility

About

The accumulation of unpaired α-globin chains in β-thalassemia major patients may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, has been known as a potent scavenger of lipid radicals in the red cell membrane of β-thalassemia major patient. By this randomized controlled trial, the investigators would like to evaluate the effects of α-tocopherol in hemolysis and oxidative stress on the red cell membrane of β-thalassemia major.

Full description

Background: The accumulation of unpaired α-globin chains in β-thalassemia major patients may clinically create ineffective erythropoiesis, hemolysis, and chronic anemia. Multiple blood transfusions and iron overload cause cellular oxidative damage. However, α-tocopherol, an antioxidant, has been known as a potent scavenger of lipid radicals in the red cell membrane of β-thalassemia major patients.

Purpose: To evaluate the effects of α-tocopherol in hemolysis and oxidative stress on the red cell membrane of β-thalassemia major.

Methods: In this randomized controlled trial, the investigators allocated subjects in the placebo and α-tocopherol groups. Doses of α-tocopherol were based on the recommendation of Institute of Medicine: 4-8 years old 200 mg/day; 9-13 years old 400 mg/day; 14-18 years old 600 mg/day. Hemolysis, oxidative stress, and antioxidant variables were evaluated before and after 4 weeks of consuming either α-tocopherol or placebo, performed prior to blood transfusions.

Enrollment: 40 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• received frequent transfusions,
• iron chelation
• aged 5 - 18-year-olds
• with no other hematologic disorders
• does not consume any other antioxidants or herbal supplements

Exclusion criteria

• the acute or chronic infection including hepatitis B or hepatitis C,
• splenectomy
• liver failure
• abnormality level of lipid test

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Alpha-Tocopgerol

Active Comparator group

Description:

Alpha-Tocopherol supplementation will be given orally for 4 weeks with doses adjusted by age. 5-8 years old: 200 mg daily, 9-13 years old: 400 mg daily and 14-18 years old 600 mg daily.

Treatment:

Drug: Alpha-Tocopherol

Drug: Placebo oral tablet

Control

Placebo Comparator group

Description:

Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation.

Treatment:

Drug: Alpha-Tocopherol

Drug: Placebo oral tablet