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Ethnic Differences in Iron Absorption (FeGenes)

Ethnic Differences in Iron Absorption

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04198545
Acronym
FeGenes
Enrollment
515
Registered
2019-12-13
Start date
2019-08-01
Completion date
2025-12-31
Last updated
2025-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Iron Deficiency, Iron Overload

Keywords

Iron absorption, Genetics

Brief summary

This study aims to; 1) investigate population differences in iron absorption between East Asians and Northern Europeans; 2) assess population differences in hormonal and biochemical determinants of Fe absorption between East Asians and Northern Europeans; and 3) to investigate genetic contributions to Fe absorption, Fe status and Fe regulatory hormones between East Asians and Northern Europeans.

Detailed description

Detailed description: This study will utilize a multidisciplinary approach to identify genetic variation in genes that control iron utilization in order to shed light on the genetic basis of population differences in iron status and disease susceptibility with a long-term goal of informing population-specific dietary iron intake recommendations to minimize the risk of chronic diseases. To evaluate iron utilization, we will employ an in vivo, functional approach using an oral stable iron isotope method. Each participant will have genetic ancestry and genotyping evaluated using the Illumina Global Diversity Array-8. Study participants (n=504, aged 18-50 y) will consume 57Fe (as ferrous sulfate) in the fasted state and will then ingest a standardized breakfast and lunch meal. Two weeks after iron dosing, a blood sample will be collected from each participant and the amount of 57Fe incorporated into red blood cells will be measured using magnetic sector thermal ionization mass spectrometry. This project will fundamentally advance our understanding of ethnic differences in nutrient metabolism and iron status. It will also provide information to assist with the long-term goal of reducing the public health burden of Fe-related diseases.

Interventions

None listed

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH
Cornell University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy adults * Age between 18- 50y * Non-smoking * Not taking vitamin or mineral supplements. * Females: premenopausal and not pregnant or lactating * No preexisting medical complications (such as eating disorders, hemoglobinopathies, malabsorption diseases, steroid use, substance abuse history, or taking medications known to influence iron homeostasis) * Body mass index (BMI) between 18 - 30 kg/m2.

Exclusion criteria

* BMI \<18 or \> 30 kg/m2, * Age \<18 y or \> 50y, * Not of Northern European or East Asian ancestry * Smoking * Pregnancy, lactating * Have gastrointestinal disorders/malabsorption diseases/hemoglobinopathies/dietary restrictions/steroid use/ medication use of medications known to impact iron status, iron utilization or inflammatory status * Take vitamin and mineral supplementations

Design outcomes

Primary

MeasureTime frameDescription
The percent of non-heme iron absorption2-weekThe percent of non-heme iron absorption will be determined by red blood cell iron incorporation of stable 57Fe
The concentrations of iron and micronutrient status indicatorsbaseline and two-weeks post dosingThe concentrations or serum folate, B12, hemoglobin, hematocrit, transferrin receptor, hepcidin, erythropoietin, erythroferrone, ferritin, interleukin-6, and c-reactive protein
Genetic ancestry and characterization of iron-related genotypesbaselineThe DNA will be extracted from whole blood samples and each participant will have genetic ancestry and genotyping evaluated using the Illumina Global Diversity Array-8.
Habitual dietary informationbaselineHabitual dietary information will be obtained from Diet History Questionnaire III .
Dietary information on the study daybaselineDetailed dietary information about all foods and beverages consumed on the study day will be obtained from the Automated Self-Administered 24-Hour Dietary Assessment Tool.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026