Completed

Serial Phlebotomy in Voluntary Blood Donors

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What is being tested

Phlebotomy

Other
Who is being recruted

Arterial Occlusive Diseases+2

+ Arteriosclerosis

+ Cardiovascular Diseases

From 40 to 70 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: June 2009
See protocol details

Summary

Principal SponsorNYU Langone Health
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitleSerial Phlebotomy in Voluntary Blood Donors
NCT02762422
Principal SponsorNYU Langone Health
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

84 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesAtherosclerosis

Criteria

2 inclusion criteria required to participate
hemoglobin levels >13.5 g/dl for men, or >12.5 g/dl for women
serum ferritin 50-400 ng/ml
15 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose

Group II

Experimental
Four serial phlebotomy procedures followed by infusion of normal saline

Group III

Placebo
Four serial sham phlebotomy procedures followed by infusion of normal saline

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

New York University Langone Medical Center

New York, United StatesOpen New York University Langone Medical Center in Google Maps
CompletedOne Study Center