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Active, not recruitingNCT04198545FeGenesUpdated Oct 23, 2026

Ethnic Differences in Iron Absorption (FeGenes)

An observational study in Anemia, Iron Deficiency and Iron Overload, sponsored by Cornell University. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Cornell University · Observational

Updated Oct 23, 2026Study completion movedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
515
Ages
18 Years to 50 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Anemia, Iron Deficiency
  • Iron Overload

Keywords

  • Iron absorption
  • Genetics
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In context

Anemia, Iron-Deficiency

600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.

This study's enrollment of 515 is above the median of 200 across 118 observational studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Cornell University is the lead sponsor of 103 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy adults from Ithaca and Rochester, NY

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, use, substance abuse history, or taking medications known to influence iron homeostasis)
  • (BMI) between 18 - 30 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • \<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/ use/ medication use of medications known to impact iron status, iron utilization or inflammatory status
  • Take vitamin and mineral supplementations
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
515 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. The percent of non-heme iron absorption

    The percent of non-heme iron absorption will be determined by red blood cell iron incorporation of stable 57Fe

    Time frame: 2-week

  2. The concentrations of iron and micronutrient status indicators

    The concentrations or serum folate, B12, hemoglobin, hematocrit, transferrin receptor, hepcidin, erythropoietin, erythroferrone, ferritin, interleukin-6, and c-reactive protein

    Time frame: baseline and two-weeks post dosing

  3. Genetic ancestry and characterization of iron-related genotypes

    The 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.

    Time frame: baseline

  4. Habitual dietary information

    Habitual dietary information will be obtained from Diet History Questionnaire III .

    Time frame: baseline

  5. Dietary information on the study day

    Detailed 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.

    Time frame: baseline

07

Study locations

2 sites
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References and documents

Publications

  • Lee MR, Barad A, Bender E, Thompson J, Gu Z, Pressman EK, O'Brien KO. Differential associations between menstrual blood loss scores and iron status in East Asian and Northern European individuals: findings from a cross-sectional analysis of the Iron Genes in East Asian and Northern European Adults Study (FeGenes) cohort. Am J Clin Nutr. 2026 Jun;123(6):101326. doi: 10.1016/j.ajcnut.2026.101326. Epub 2026 Apr 25. PubMed 42044770 ↗
  • Barad A, Xu H, Clark AG, Gu Z, Pressman EK, Ye K, O'Brien KO. A genetic association study of iron absorption in adults of East Asian or Northern European ancestry from the Iron Genes in East Asian and Northern European Adults Study (FeGenes). Am J Clin Nutr. 2026 Jun;123(6):101298. doi: 10.1016/j.ajcnut.2026.101298. Epub 2026 Mar 25. PubMed 41895699 ↗
  • Park CY, Barad A, Xu Y, Bender E, Thomas AK, Haller CM, Gu Z, Pressman EK, O'Brien KO. Dietary intake in East Asian and Northern European participants from the FeGenes study. Eur J Nutr. 2025 Jun 5;64(5):205. doi: 10.1007/s00394-025-03730-w. PubMed 40471375 ↗
  • Barad A, Xu Y, Bender E, Pressman EK, Gu Z, O'Brien KO. Differences in nonheme iron absorption between healthy adults of East Asian or Northern European ancestry from the Iron Genes in East Asian and Northern European Adults Study (FeGenes): A cross-sectional stable iron isotope study. Am J Clin Nutr. 2025 Feb;121(2):417-426. doi: 10.1016/j.ajcnut.2024.11.015. PubMed 39909711 ↗
  • Barad A, Xu Y, Bender E, Pressman EK, Gu Z, O'Brien KO. Iron regulatory hormones and their associations with iron status biomarkers among healthy adults of East Asian or Northern European ancestry: A cross-sectional comparison from the Iron Genes in East Asian and Northern European Adults Study (FeGenes). Am J Clin Nutr. 2025 Feb;121(2):406-416. doi: 10.1016/j.ajcnut.2024.10.018. PubMed 39909710 ↗
  • Barad A, Xu Y, Bender E, Kang W, Xu R, Gu Z, Pressman EK, O'Brien KO. Characterization of iron status biomarkers and hematological indices among young adults of East Asian or Northern European ancestry: A cross-sectional analysis from the Iron Genes in East Asian and Northern European Adults Study (FeGenes). Am J Clin Nutr. 2025 Feb;121(2):394-405. doi: 10.1016/j.ajcnut.2024.10.014. PubMed 39909709 ↗
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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Aug 2019 to primary completion in Oct 2023, 50 months.

Completion moved once since we started tracking on Sep 25, 2026: Dec 2025 → Dec 2026, on Oct 23, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2019
First posted
Dec 13, 2019
StartActual
Aug 1, 2019
Primary completionActual
Oct 16, 2023
CompletionEst.
Dec 31, 2026was Dec 2025
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Study completion
Dec 31, 2025→Dec 31, 2026
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Study completion Dec 31, 2025→Dec 31, 2026
    + 3 other changes: verification date, oversight details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04198545
Lead sponsor
Cornell University
Responsible party
Sponsor
First posted
Dec 13, 2019
Start date
Aug 1, 2019
Primary completion
Oct 16, 2023
Completion
Dec 31, 2026 (estimated)
Last update
Oct 23, 2026

Study contacts

Kimberly O O'Brien
principal investigator · Cornell University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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