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Iron Status in Women of Reproductive Age Reproductive Age

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03276247
Enrollment
22042
Registered
2017-09-08
Start date
2016-01-01
Completion date
2017-08-01
Last updated
2017-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron Metabolism Disorders

Brief summary

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.

Detailed description

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.

Interventions

OTHERobservation

observation

Sponsors

Weill Medical College of Cornell University
CollaboratorOTHER
Victor Gordeuk
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 44 Years

Inclusion criteria

1. primary care women included in the HEIRS study with in the age range of this study 2. Self designation as Asian American, African American, Hispanic American or White.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Elevated serum ferritinOne measurement was made at the time of recruitment and this is the measurement that will be analyzed.Serum ferritin \>300 ug/L
Elevated serum ferritin and transferrin saturationOne 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%
Iron deficiencyOne measurement was made at the time of recruitment and this is the measurement that will be analyzed.Serum ferritin \<15ug/L

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026