Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03276247
Other study ID # HEIRS-womenrepage
Secondary ID
Status Completed
Phase N/A
First received September 1, 2017
Last updated September 7, 2017
Start date January 1, 2016
Est. completion date August 1, 2017

Study information

Verified date September 2017
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 22042
Est. completion date August 1, 2017
Est. primary completion date August 1, 2017
Accepts healthy volunteers
Gender Female
Age group 25 Years to 44 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
observation
observation

Locations

Country Name City State
United States University of Illinois at Chicago Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Victor Gordeuk Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
Primary Iron deficiency Serum ferritin <15ug/L One measurement was made at the time of recruitment and this is the measurement that will be analyzed.
See also
  Status Clinical Trial Phase
Completed NCT03990181 - Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement N/A
Recruiting NCT06213402 - RADeep Multicenter European Epidemiological Platform for Patients Diagnosed With Rare Anemia Disorders (RADs)
Withdrawn NCT01927913 - Treatment of Iron Overload Requiring Chelation Therapy Phase 2
Completed NCT03317873 - The Effect of Genetic Variation in TMPRSS6 Gene (SNP rs855791) on Oral Iron Absorption: an Iron Stable Isotope Study N/A
Enrolling by invitation NCT03512743 - Association of Serum Ferritin and Bone Mineral Density With Bone Metabolism in Chinese Healthy Postmenopausal Women
Recruiting NCT06151548 - Effect of Krill Oil Supplementation on Red Blood Cell Physiology Against Changes in Markers of Iron Metabolism. Phase 4
Recruiting NCT00687518 - Effects of Intravenous Injection of Erythropoietin on Hepcidin Pharmacokinetics in Healthy Volunteers N/A
Not yet recruiting NCT05510440 - Supplementation With Altha-aminoacids and Systemiec Inflammatory Response in Long-distance Runners. N/A
Recruiting NCT04008147 - Hepcidin and Glucose Metabolism N/A
Recruiting NCT06250595 - European Rare Blood Disorders Platform (ENROL)
Completed NCT03013439 - Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®) Phase 1
Completed NCT01477112 - Low Dose β-carotene Supplementation Diminishes Oxidative Stress in Type 2 Diabetics and Healthy Individuals N/A
Completed NCT04458662 - Iron and Muscular Damage: FEmale Metabolism and Menstrual Cycle During Exercise
Not yet recruiting NCT02882477 - Treatment of Wolfram Syndrome Type 2 With the Chelator Deferiprone and Incretin Based Therapy Phase 2/Phase 3
Recruiting NCT05586867 - Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients