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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04198545
Other study ID # IRB # 1904008754
Secondary ID R01DK122216
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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