Ethnic Differences in Iron Absorption (FeGenes)

Iron Overload Clinical Trial

— FeGenes  

Official title:

Ethnic Differences in Iron Absorption

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04198545
• Other study ID #: IRB # 1904008754
• Secondary ID: R01DK122216
• Status: Active, not recruiting
• Start date: August 1, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 515
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron Deficiency
• Anemia, Iron-Deficiency
• Iron Overload

Locations

Country	Name	City	State
United States	Cornell University	Ithaca	New York
United States	University of Rochester	Rochester	New York

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2-week
Primary	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	baseline and two-weeks post dosing
Primary	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.	baseline
Primary	Habitual dietary information	Habitual dietary information will be obtained from Diet History Questionnaire III .	baseline
Primary	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.	baseline