Iron Status in Women of Reproductive Age Reproductive Age

Sponsor
Victor Gordeuk (Other)
Overall Status
Completed
CT.gov ID
NCT03276247
Collaborator
Weill Medical College of Cornell University (Other)
22,042
1
19
1160.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: observation

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.

Study Design

Study Type:
Observational
Actual Enrollment :
22042 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Ethnic and Genetic Factors of Iron Status in Women of Reproductive Age
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Asian American non-pregnant

Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and non-pregnant/non-breastfeeding.

Other: observation
observation

African American non-pregnant

Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and non-pregnant/non-breastfeeding.

Other: observation
observation

Hispanic American non-pregnant

Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and non-pregnant/non-breastfeeding.

Other: observation
observation

White non-pregnant

Women 25 to 44 years of age recruited in a primary care setting and self reported as white and non-pregnant/non-breastfeeding.

Other: observation
observation

Asian American pregnant

Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and pregnant or breastfeeding.

Other: observation
observation

African American pregnant

Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and pregnant or breastfeeding.

Other: observation
observation

Hispanic American pregnant

Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and pregnant or breastfeeding.

Other: observation
observation

White pregnant

Women 25 to 44 years of age recruited in a primary care setting and self reported as White and pregnant or breastfeeding.

Other: observation
observation

Outcome Measures

Primary Outcome Measures

  1. Elevated serum ferritin [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 [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 [One measurement was made at the time of recruitment and this is the measurement that will be analyzed.]

    Serum ferritin <15ug/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 44 Years
Sexes Eligible for Study:
Female
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois at Chicago Chicago Illinois United States 60612

Sponsors and Collaborators

  • Victor Gordeuk
  • Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Victor R Gordeuk, MD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Victor Gordeuk, Professor of Medicine, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT03276247
Other Study ID Numbers:
  • HEIRS-womenrepage
First Posted:
Sep 8, 2017
Last Update Posted:
Sep 8, 2017
Last Verified:
Sep 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2017