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Iron Status in Women of Reproductive Age Reproductive Age

V

Victor Gordeuk

Status

Completed

Conditions

Iron Metabolism Disorders

Treatments

Other: observation

Study type

Observational

Funder types

Other

Identifiers

NCT03276247
HEIRS-womenrepage

Details and patient eligibility

About

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.

Full 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.

Enrollment

22,042 patients

Sex

Female

Ages

25 to 44 years old

Volunteers

No Healthy Volunteers

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.

Trial design

22,042 participants in 8 patient groups

Asian American non-pregnant
Description:
Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and non-pregnant/non-breastfeeding.
Treatment:
Other: observation
African American non-pregnant
Description:
Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and non-pregnant/non-breastfeeding.
Treatment:
Other: observation
Hispanic American non-pregnant
Description:
Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and non-pregnant/non-breastfeeding.
Treatment:
Other: observation
White non-pregnant
Description:
Women 25 to 44 years of age recruited in a primary care setting and self reported as white and non-pregnant/non-breastfeeding.
Treatment:
Other: observation
Asian American pregnant
Description:
Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and pregnant or breastfeeding.
Treatment:
Other: observation
African American pregnant
Description:
Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and pregnant or breastfeeding.
Treatment:
Other: observation
Hispanic American pregnant
Description:
Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and pregnant or breastfeeding.
Treatment:
Other: observation
White pregnant
Description:
Women 25 to 44 years of age recruited in a primary care setting and self reported as White and pregnant or breastfeeding.
Treatment:
Other: observation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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