The Effect of Alpha-tocopherol in Hemolysis and Oxidative Stress Marker on the Red Cell
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double masking. No any information about treatment or placebo in participant, investigator, care provider and outcome assessor
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •received frequent transfusions,
- •iron chelation
- •aged 5 - 18-year-olds
- •with no other hematologic disorders
- •does not consume any other antioxidants or herbal supplements
排除标准
- •the acute or chronic infection including hepatitis B or hepatitis C,
- •splenectomy
- •liver failure
- •abnormality level of lipid test
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Placebo oral tablet (Drug)
Control
Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation.
干预措施: Alpha-Tocopherol (Drug)
Control
Placebo is the drug with the same shape and color as the alpha-tocopherol supplementation.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
The effects of α-tocopherol in hemolysis marker on the red cell membrane of β-thalassemia major
时间窗: 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
次要结局
- 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)
研究者
Nora Sovira
Principal Investigator
Indonesia University