Iron Status in Women of Reproductive Age Reproductive Age

Ethnic and Genetic Factors of Iron Status in Women of 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.

Study Overview

• Status: Completed
• Conditions: Iron Metabolism Disorders
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 22042

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 44 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Primary care women included in the HEIRS study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Elevated serum ferritin	Serum ferritin >300 ug/L	One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Elevated serum ferritin and transferrin saturation	Serum ferritin >200 ug/L and transferrin saturation >45%	One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
Iron deficiency	Serum ferritin <15ug/L	One measurement was made at the time of recruitment and this is the measurement that will be analyzed.

Collaborators and Investigators

• Sponsor: Victor Gordeuk
• Collaborators: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Victor R Gordeuk, MD, University of Illinois at Chicago

Publications and helpful links

General Publications

• Gordeuk VR, Brannon PM. Ethnic and genetic factors of iron status in women of reproductive age. Am J Clin Nutr. 2017 Dec;106(Suppl 6):1594S-1599S. doi: 10.3945/ajcn.117.155853. Epub 2017 Oct 25.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders
• Other Study ID Numbers: HEIRS-womenrepage

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No