NCT00005541

Brief Summary

To determine the prevalence, genetic and environmental determinants, and potential clinical, personal, and societal impact of iron overload and hereditary hemochromatosis, in a multi-center, multiethnic, primary care-based sample of 100,000 adults. The study is conducted by the Division of Epidemiology and Clinical Applications of the NHLBI, the Division of Blood Diseases and Resources of the NHLBI, and the Ethical, Legal, and Social Implications (ELSI) Research Program of the NHGRI.

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

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

January 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

April 14, 2016

Status Verified

April 1, 2009

Enrollment Period

6 years

First QC Date

May 25, 2000

Last Update Submit

April 13, 2016

Conditions

Eligibility Criteria

Age25 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (3)

  • McLaren CE, Barton JC, Adams PC, Harris EL, Acton RT, Press N, Reboussin DM, McLaren GD, Sholinsky P, Walker AP, Gordeuk VR, Leiendecker-Foster C, Dawkins FW, Eckfeldt JH, Mellen BG, Speechley M, Thomson E; Hemochromatosis and Iron Overload Study Research Investigators. Hemochromatosis and Iron Overload Screening (HEIRS) study design for an evaluation of 100,000 primary care-based adults. Am J Med Sci. 2003 Feb;325(2):53-62. doi: 10.1097/00000441-200302000-00001.

    PMID: 12589228BACKGROUND
  • Adams PC, Reboussin DM, Leiendecker-Foster C, Moses GC, McLaren GD, McLaren CE, Dawkins FW, Kasvosve I, Acton RT, Barton JC, Zaccaro D, Harris EL, Press R, Chang H, Eckfeldt JH. Comparison of the unsaturated iron-binding capacity with transferrin saturation as a screening test to detect C282Y homozygotes for hemochromatosis in 101,168 participants in the hemochromatosis and iron overload screening (HEIRS) study. Clin Chem. 2005 Jun;51(6):1048-52. doi: 10.1373/clinchem.2005.048371. Epub 2005 Apr 15. No abstract available.

    PMID: 15833784BACKGROUND
  • Adams PC, Reboussin DM, Barton JC, McLaren CE, Eckfeldt JH, McLaren GD, Dawkins FW, Acton RT, Harris EL, Gordeuk VR, Leiendecker-Foster C, Speechley M, Snively BM, Holup JL, Thomson E, Sholinsky P; Hemochromatosis and Iron Overload Screening (HEIRS) Study Research Investigators. Hemochromatosis and iron-overload screening in a racially diverse population. N Engl J Med. 2005 Apr 28;352(17):1769-78. doi: 10.1056/NEJMoa041534.

    PMID: 15858186BACKGROUND

MeSH Terms

Conditions

Hematologic DiseasesHemochromatosisIron Overload

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesMetal Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ronald Acton

    University of Alabama at Birmingham

  • Paul Adams

    London Health Sciences Centre

  • John Eckfeldt

    University of Minnesota

  • Victor Gordeuk

    Howard University

  • Emily Harris

    Kaiser Foundation Research Institute

  • Christine McLaren

    University of California

  • David Reboussin

    Wake Forest University

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

January 1, 2000

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

April 14, 2016

Record last verified: 2009-04