Serial Phlebotomy in Voluntary Blood Donors

Completed · Not applicable · Has a placebo group

Conditions studied: Atherosclerosis

In brief

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.

Key facts

Study ID

NCT02762422

Run by

NYU Langone Health

People needed

84

Starts

2009-06-01

Expected to finish

2012-08-01

Last updated by the study team

2016-05-05

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• hemoglobin levels >13.5 g/dl for men, or >12.5 g/dl for women
• serum ferritin 50-400 ng/ml

You may not qualify if…

• 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

Where it is running

• New York University Langone Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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