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Ethnic Differences in Iron Absorption (FeGenes) (FeGenes)

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ClinicalTrials.gov Identifier: NCT04198545
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : January 2, 2020
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Cornell University

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.

Condition or disease
Anemia, Iron Deficiency Iron Overload

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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Study Type : Observational
Estimated Enrollment : 552 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Ethnic Differences in Iron Absorption
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
Serum and DNA samples will be collected.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults from Ithaca, NY
Criteria

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,
  • Nt 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
  • Blood donors.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04198545


Contacts
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Contact: Kimberly O O'Brien 6072553743 koo4@cornell.edu
Contact: Zhenglong Gu 6072545144 zg27@cornell.edu

Locations
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United States, New York
Cornell University Recruiting
Ithaca, New York, United States, 14853
Sponsors and Collaborators
Cornell University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Kimberly O O'Brien Cornell University
Principal Investigator: Zhenglong Gu Cornell University
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Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT04198545    
Other Study ID Numbers: IRB # 1904008754
R01DK122216 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cornell University:
Iron absorption
Genetics
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Iron Overload
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases