Role of Vitamin E in Enhancing Erythropoiesis and the Molecular Mechanism of the Action of Vitamin E on Erythropoietin-secreting Cells
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 1
- 主要终点
- Change in hemoglobin levels
研究概览
简要总结
Anemia is one of the major health problems of the developing countries of the world [1]. According to the WHO reference criteria, an adult is labeled as anemic, if the blood hemoglobin concentration falls below 13.0 g/dL in men or less than 12.0 g/dL in the non-pregnant women [2]. Hemoglobin concentrations below the lower limit of normal are a common laboratory finding in apparently healthy people in general population all over the world [3-5]. Many of these mildly anemic individuals are not investigated sufficiently to establish the probable cause of their anemia and thus may end up with morbidity and health problems, especially the young women in developing countries [4].
Only few studies on the use of vitamin E in the correction of anemia have been published and hardly any on correction of mild anemia in healthy adults. The objective of this intervention study was to investigate the association of vitamin E supplementation with post-supplemental blood hemoglobin levels in mildly anemic healthy Pakistani adults.
详细描述
Anemia is one of the major health problems of the developing countries of the world [1]. According to the WHO reference criteria, an adult is labeled as anemic, if the blood hemoglobin concentration falls below 13.0 g/dL in men or less than 12.0 g/dL in the non-pregnant women [2]. Hemoglobin concentrations below the lower limit of normal are a common laboratory finding in apparently healthy people in general population all over the world [3-5]. Many of these mildly anemic individuals are not investigated sufficiently to establish the probable cause of their anemia and thus may end up with morbidity and health problems, especially the young women in developing countries [4].
A few human studies during the past few years have suggested the possible use of antioxidant vitamins in the correction of anemia [6]. Vitamin E is an essentially required lipophilic vitamin with a variety of antioxidant and non-antioxidant functions. It has been shown that treatment with vitamin E resulted in increased number of colony forming units of erythroid precursors in experimental animals and protected their bone marrow against drug- induced toxicity [7]. In some of the clinical trials in patients with hematological disorders, vitamin E supplementation showed decrease in red blood cell deformability and enhanced blood hemoglobin levels [8,9]. Although clinical benefits of vitamin E on increasing hemoglobin levels in some disease states have been published, yet its effect on a presumably healthy adult population with no abnormality other than mild anemia has hardly been reported.
Hypothesis:
Vitamin E supplementation for three months to mildly anemic healthy adults (with no past history of any iron supplements) would result into improved post-supplemental levels of blood hemoglobin compared to their basal levels.
Objective of the present study: To investigate the association of vitamin E supplementation in mildly anemic healthy adults with the post-supplemental blood hemoglobin levels in a general population of Karachi, Pakistan.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •mildly anemic (on the basis of screening) volunteer males and non-pregnant and non-lactating females, giving written informed consent.
- •normolipidemic, normotensive
- •no history of: i. diabetes, hyperlipidemia, obesity, asthma, cancer, respiratory, cardiovascular, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, sexually-transmitted disease, during the last 5 years.
- •ii. severe acute or chronic blood loss during last 6 months. iii. bleeding or clotting abnormality during last 1 year. iv. regular cigarette smoking, tobacco chewing v. consumption of vitamin E, vitamin B12, folate, iron or antioxidant during the last 6 months prior to enrollment.
排除标准
- •pregnant and lactating females.
- •cigarette smoking, tobacco chewing, alcohol consumers
- •blood transfusions during the last 1 year
- •history of diabetes mellitus, hypertension, dyslipidemia , obesity asthma, cancer, respiratory, renal, nervous, gastrointestinal, hepatic, urogenital, musculoskeletal, endocrine, psychiatric, cardiovascular disorder/disease during the last five years.
- •severe acute blood loss during last 6 months.
- •bleeding or clotting abnormalities during the last 1 year.
- •consumed vitamin E, B12, folate, iron or antioxidants supplements during the last 6 months.
研究组 & 干预措施
Intervention (Vitamin E supplementation)
Vitamin E 400 mg once daily for 3 months
干预措施: Vitamin E (Drug)
placebo (edible oil)
干预措施: placebo (edible oil) (Drug)
结局指标
主要结局
Change in hemoglobin levels
时间窗: Change in hemoglobin levels in mildly anemic adults at baseline and after 3 months of intervention (vitamin E or placebo) in all the participants in intervention arm and placebo arm (end-line).
Hemoglobin levels in blood were determined in mildly anemic adults before intervention (baseline) and after 3 months of supplementation with vitamin E 400 mg per day (end-line).
次要结局
未报告次要终点
研究者
Dr. Tanveer Jilani
Senior Instructor
Aga Khan University