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
|Condition or disease|
|Anemia, Iron Deficiency Iron Overload|
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 Type :||Observational|
|Estimated Enrollment :||552 participants|
|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|
- 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
- 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
- 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.
- Habitual dietary information [ Time Frame: baseline ]Habitual dietary information will be obtained from Diet History Questionnaire III .
- 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
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
|Contact: Kimberly O O'Brienemail@example.com|
|Contact: Zhenglong Gufirstname.lastname@example.org|
|United States, New York|
|Ithaca, New York, United States, 14853|
|Principal Investigator:||Kimberly O O'Brien||Cornell University|
|Principal Investigator:||Zhenglong Gu||Cornell University|