Iron Status in Women of Reproductive Age Reproductive Age
- Conditions
- Iron Metabolism Disorders
- Interventions
- Other: observation
- Registration Number
- NCT03276247
- Lead Sponsor
- Victor Gordeuk
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 22042
- primary care women included in the HEIRS study with in the age range of this study
- Self designation as Asian American, African American, Hispanic American or White.
- Age >44 years
- Self-described ethnicity other in than inclusion criterion 2.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Asian American pregnant observation Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and pregnant or breastfeeding. African American pregnant observation Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and pregnant or breastfeeding. African American non-pregnant observation Women 25 to 44 years of age recruited in a primary care setting and self reported as African American and non-pregnant/non-breastfeeding. Hispanic American pregnant observation Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and pregnant or breastfeeding. Asian American non-pregnant observation Women 25 to 44 years of age recruited in a primary care setting and self reported as Asian American and non-pregnant/non-breastfeeding. Hispanic American non-pregnant observation Women 25 to 44 years of age recruited in a primary care setting and self reported as Hispanic American and non-pregnant/non-breastfeeding. White pregnant observation Women 25 to 44 years of age recruited in a primary care setting and self reported as White and pregnant or breastfeeding. White non-pregnant observation Women 25 to 44 years of age recruited in a primary care setting and self reported as white and non-pregnant/non-breastfeeding.
- Primary Outcome Measures
Name Time Method 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
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%
Iron deficiency One measurement was made at the time of recruitment and this is the measurement that will be analyzed. Serum ferritin \<15ug/L
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States