Clinical Trials Directory

Trials / Completed

CompletedNCT03276247

Iron Status in Women of Reproductive Age Reproductive Age

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

Status
Completed
Phase
Study type
Observational
Enrollment
22,042 (actual)
Sponsor
Victor Gordeuk · Academic / Other
Sex
Female
Age
25 Years – 44 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
OTHERobservationobservation

Timeline

Start date
2016-01-01
Primary completion
2017-08-01
Completion
2017-08-01
First posted
2017-09-08
Last updated
2017-09-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03276247. Inclusion in this directory is not an endorsement.