Ethnic Differences in Iron Absorption (FeGenes)

Sponsor

Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04198545

Collaborator

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

552

Enrollment

Locations

Anticipated Duration (Months)

276

Patients Per Site

6.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

552 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Ethnic Differences in Iron Absorption

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

The percent of non-heme iron absorption [2-week]
The 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 indicators [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
Genetic ancestry and characterization of iron-related genotypes [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.
Habitual dietary information [baseline]
Habitual dietary information will be obtained from Diet History Questionnaire III .
Dietary information on the study day [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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
Blood donors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cornell University	Ithaca	New York	United States	14853
2	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

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

Investigators

Principal Investigator: Kimberly O O'Brien, Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cornell University

ClinicalTrials.gov Identifier:

NCT04198545

Other Study ID Numbers:

IRB # 1904008754
R01DK122216

First Posted:

Dec 13, 2019

Last Update Posted:

Mar 11, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cornell University

Iron absorption

Genetics

Additional relevant MeSH terms:

Anemia, Iron-Deficiency

Iron Overload

Study Results

No Results Posted as of Mar 11, 2022