Clinical trial NCT03948737: The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell Membrane Beta-thalassemia Major
Official title: The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta Thalassemia Major Anemia
Hemolysis
Oxidative Stress
Keywords: Haptoglobin
Hemopexin
Hemolysis
Malondialdehyde
Glutathione
Oxidative stress
Alpha-Tocopherol
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Beta thalassemia major children
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major
timeFrame: 4 weeks
Secondary outcomes:
measure: The effects of α-tocopherol in oxidative stress marker on the red cell membrane of β-thalassemia major
timeFrame: 4 weeks
measure: The effects of α-tocopherol in endogenous antioxidant on the red cell membrane of β-thalassemia major
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Thalassemia Centre Kiara RSUP Dr.CiptoMangunkusumo
state: Jakarta
Study officials:
affiliation: Hematology Oncologist Head Division of Child Health of Universitas Indonesia
name: Pustika Amalia, Consultant
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ghone RA, Kumbar KM, Suryakar AN, Katkam RV, Joshi NG. Oxidative stress and disturbance in antioxidant balance in beta thalassemia major. Indian J Clin Biochem. 2008 Oct;23(4):337-40. doi: 10.1007/s12291-008-0074-7. Epub 2008 Dec 20.