Beta Thalassemia Major Anemia, Hemolysis, Oxidative Stress
Conditions
Keywords
Haptoglobin, Hemopexin, Hemolysis, Malondialdehyde, Glutathione, Oxidative stress, Alpha-Tocopherol
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.
Interventions
DRUGAlpha-Tocopherol
all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.
DRUGPlacebo oral tablet
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double masking. No any information about treatment or placebo in participant, investigator, care provider and outcome assessor
Intervention model description
Beta thalassemia major children
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major | 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
| Measure | Time frame | Description |
|---|---|---|
| The effects of α-tocopherol in oxidative stress marker on the red cell membrane of β-thalassemia major | 4 weeks | The malondialdehyde plasma level as oxidative stress marker on alpha-tocopherol treatment was assessed by Spectrophotometry using TBARS method. |
| The effects of α-tocopherol in endogenous antioxidant on the red cell membrane of β-thalassemia major | 4 weeks | The Glutathione as endogenous antioxidant marker on alpha-tocopherol treatment was assessed by ELISA method by using GT40 for Glutathione kit |
Countries
Indonesia
Outcome results
None listed