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Active, Not Recruiting

NCT Number: NCT04198545

Ethnic Differences in Iron Absorption (FeGenes)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anemia, Iron Deficiency Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Iron Overload Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cornell University, Ithaca, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The percent of non-heme iron absorption

    Time frame: 2-week

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

  2. The concentrations of iron and micronutrient status indicators

    Time frame: baseline and two-weeks post dosing

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

  3. Genetic ancestry and characterization of iron-related genotypes

    Time frame: baseline

    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.

  4. Habitual dietary information

    Time frame: baseline

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

  5. Dietary information on the study day

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

Cornell University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

Ethnic Differences in Iron Absorption

Acronym: FeGenes

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Dec 13, 2019
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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