NCT02762422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

3.2 years

First QC Date

May 2, 2016

Last Update Submit

May 4, 2016

Conditions

Atherosclerosis

Keywords

endothelial functioniron storesred blood cellblood donation

Outcome Measures

Primary Outcomes (1)

  • Brachial artery reactivity response to oral methionine administration

    Measure by vascular ultrasound imaging

    Before and 1 week after completion of assigned phlebotomy procedures

Secondary Outcomes (1)

  • Iron deficiency anemia

    before each phlebotomy procedure, and at 1, 8, and 16 weeks after completion of assigned phlebotomy procedures

Other Outcomes (3)

  • 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

Study Arms (3)

Phlebotomy plus normal saline

EXPERIMENTAL

Four serial phlebotomy procedures followed by infusion of normal saline

Other: Phlebotomy

Phlebotomy plus intravenous iron

EXPERIMENTAL

Four serial phlebotomy procedures followed by infusion of intravenous iron sucrose

Other: Phlebotomy

Sham Phlebotomy

PLACEBO COMPARATOR

Four serial sham phlebotomy procedures followed by infusion of normal saline

Other: Phlebotomy

Interventions

PhlebotomyOTHER

Removal of 500 cc of blood via forearm vein

Also known as: Blood donation
Phlebotomy plus intravenous ironPhlebotomy plus normal salineSham Phlebotomy

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

PhlebotomyBlood Donation

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen CollectionSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesTherapeuticsSurgical Procedures, OperativeInvestigative TechniquesTissue and Organ ProcurementHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stuart Katz, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 5, 2016

Study Start

June 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 5, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

PI will make de-identified dataset available upon request in accord with institutional data use agreement policy

Locations

US(1)