Serial Phlebotomy in Voluntary Blood Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Brachial artery reactivity response to oral methionine administration
研究概览
简要总结
Blood donation has been proposed to be associated with reduced risk of cardiovascular disease, but the effects of phlebotomy on vascular function in human subjects have not been well characterized. A prospective randomized double-blind study was undertaken to determine the effects of iron loss and red blood cell loss induced by serial phlebotomy on vascular endothelial function in the brachial artery.
详细描述
84 Fe-replete, non-anemic subjects were randomly assigned to one of three experimental serial phlebotomy procedures designed to induce Fe loss or RBC loss. Brachial artery reactivity (BAR, %) in response to transient oxidative stress induced by oral methionine was measured with high-resolution duplex ultrasound imaging before and after study phlebotomy procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •hemoglobin levels >13.5 g/dl for men, or >12.5 g/dl for women
- •serum ferritin 50-400 ng/ml
排除标准
- •known intolerance of phlebotomy procedures
- •major trauma or surgical procedures in the last 2 years
- •menstrual or other uterine bleeding in the last 2 years
- •chronic oral anticoagulation or dual antiplatelet therapy
- •chronic non-steroidal anti-inflammatory drug use
- •known history of hemochromatosis or other disorder of hematopoiesis or Fe metabolism
- •chronic oral Fe supplementation other than Fe-containing multivitamins
- •history of active cancer in the past 2 years
- •known history of chronic inflammatory disease
- •uncontrolled hypertension
- •electrocardiographic evidence of prior myocardial infarction
- •diabetes mellitus
- •fasting glucose >100 mg/dL
- •body mass index >40 kg/m2
- •any tobacco use in the past 6 months
结局指标
主要结局
Brachial artery reactivity response to oral methionine administration
时间窗: Before and 1 week after completion of assigned phlebotomy procedures
Measure by vascular ultrasound imaging
次要结局
- Iron deficiency anemia(before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures)
研究者
Stuart Katz
Principal Investigator
NYU Langone Health