Atherosclerosis
Conditions
Keywords
endothelial function, iron stores, red blood cell, blood donation
Brief summary
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.
Detailed description
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.
Interventions
OTHERPhlebotomy
Removal of 500 cc of blood via forearm vein
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* hemoglobin levels \>13.5 g/dl for men, or \>12.5 g/dl for women * serum ferritin 50-400 ng/ml
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brachial artery reactivity response to oral methionine administration | Before and 1 week after completion of assigned phlebotomy procedures | Measure by vascular ultrasound imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iron deficiency anemia | before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures | hemoglobin level measured by hemocue or complete blood count |
Other
| Measure | Time frame |
|---|---|
| Serum ferritin | Before and 1 week after completion of assigned phlebotomy procedures |
| Serum nitrotyrosine | Before and 1 week after completion of assigned phlebotomy procedures |
| Whole blood viscosity | Before and 1 week after completion of assigned phlebotomy procedures |
Countries
United States
Outcome results
None listed