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Completed

NCT Number: NCT03276247

Iron Status in Women of Reproductive Age Reproductive Age

Analyzed iron status, HFE mutations and ethnicity for women in five primary care centers in the United States and Canada using de-identified data from the HEIRS study.

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Key information

Conditions

Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

HEIRS included a cross-sectional screening study of 101,168 patients, 25 years of age or older, in the primary care setting. Participants were recruited from four centers in the U.S .and one in Canada from February 2001 to February 2003. We will evaluate results for women aged 25-44 years of age who are self-reported as Asian, Black, Hispanic or White. The lower detection limit for the serum ferritin (SF) assay in the HEIRS study was 15 μg/L and therefore the definition of iron deficiency will be SF concentration ≤ 15 μg/L. Elevated SF concentrations, possibly indicative of elevated iron stores, will be classified by two definitions: 1) SF concentration > 300 μg/L and 2) SF >200 μg/L in combination with TSAT >45%. Proportions will be compared by Pearson's chi-square. Logistic regression models will be used to identify independent associations with measures of iron deficiency and elevated iron stores.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • primary care women included in the HEIRS study with in the age range of this study
  • Self designation as Asian American, African American, Hispanic American or White.

Exclusion criteria

  • Age >44 years
  • Self-described ethnicity other in than inclusion criterion 2.

Treatment and study plan

observation

Other

observation

Primary outcomes

  1. Elevated serum ferritin

    Time frame: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.

    Serum ferritin >300 ug/L

  2. Elevated serum ferritin and transferrin saturation

    Time frame: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.

    Serum ferritin >200 ug/L and transferrin saturation >45%

  3. Iron deficiency

    Time frame: One measurement was made at the time of recruitment and this is the measurement that will be analyzed.

    Serum ferritin <15ug/L

Sponsors and collaborators

Lead sponsor

Victor Gordeuk

Other

Collaborators

  • Weill Medical College of Cornell University

Registry information

Official study title

Ethnic and Genetic Factors of Iron Status in Women of Reproductive Age

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 8, 2017
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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