Clinical trial NCT02762422: Serial Phlebotomy in Voluntary Blood Donors
Official title: Serial Phlebotomy in Voluntary Blood Donors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Keywords: endothelial function
iron stores
red blood cell
blood donation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: National Center for Research Resources (NCRR)
First posted: 2016-05-05
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brachial artery reactivity response to oral methionine administration
timeFrame: Before and 1 week after completion of assigned phlebotomy procedures
Secondary outcomes:
measure: Iron deficiency anemia
timeFrame: before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures
Other outcomes:
measure: Serum ferritin
timeFrame: Before and 1 week after completion of assigned phlebotomy procedures
measure: Serum nitrotyrosine
timeFrame: Before and 1 week after completion of assigned phlebotomy procedures
measure: Whole blood viscosity
timeFrame: Before and 1 week after completion of assigned phlebotomy procedures
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Stuart Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: