The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Indonesia University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double masking. No any information about treatment or placebo in participant, investigator, care provider and outcome assessor
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Alpha-Tocopgerol
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.
Intervention: Alpha-Tocopherol (Drug)
Alpha-Tocopgerol
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.
Intervention: Placebo oral tablet (Drug)
Control
Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation.
Intervention: Alpha-Tocopherol (Drug)
Control
Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation.
Intervention: Placebo oral tablet (Drug)
Outcomes
Primary Outcomes
The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major
Time Frame: 4 weeks
The plasma haptoglobin and hemolysis as hemolysis marker on alpha-tocopherol treatment were assessed by ELISA using Haptoglobin and Hemopexin kit for human
Secondary Outcomes
- The effects of α-tocopherol in oxidative stress marker on the red cell membrane of β-thalassemia major(4 weeks)
- The effects of α-tocopherol in endogenous antioxidant on the red cell membrane of β-thalassemia major(4 weeks)
Investigators
Nora Sovira
Principal Investigator
Indonesia University