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Ethnic Differences in Iron Absorption (FeGenes)

C

Cornell University

Status

Active, not recruiting

Conditions

Iron Overload
Anemia, Iron Deficiency

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04198545
IRB # 1904008754
R01DK122216 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

515 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

2

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Central trial contact

Kimberly O O'Brien

Data sourced from clinicaltrials.gov

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