Genetic Variants and Iron Absorption

Completed

• Conditions: Iron Absorption

• Registration Number: NCT02197624
• Lead Sponsor: Cornell University

Brief Summary

The two specific aims of this study are: 1) to assess the impact of a genetic variant on iron status; 2) to assess the impact of a genetic variant on non-heme absorption among Asian women. The investigators hypothesize that the genetic variant could enhance iron status and iron absorption in Asian women.

Detailed Description

To determine the HFE genotype of female Asian study volunteers, we collected venous blood samples and extracted DNA from these blood samples. HFE genotype was determined as CC, CT, and TT and used to assess possible differences in iron status as a function of genotype. To measure the impact of genotype on non-heme Fe absorption, a sub-group of women with the CC (n=10) or TT (n=11) genotype were invited to return for an Fe absorption study. Each volunteer consumed stable 57Fe (as ferrous sulfate). Two weeks after ingesting this tracer, a blood sample was collected from each woman and the amount of non-heme (57Fe) iron incorporated into red blood cells was measured with magnetic sector thermal ionization mass spectrometry. Possible associations between iron status and iron absorption as a function of genotypes were explored. Data from this study will provide information that aims to improve human health by better understanding the iron requirements of individuals with different genetic background.

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2013-04
• Study Completion: 2014-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-21
• Last Update Submitted: 2014-07-21
• Study First Posted: 2014-07-23
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

Inclusion Criteria

• non-pregnant and between the ages of 18~35 y
• East Asian descent with both maternal and paternal grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand, Malaysia and Singapore

Exclusion Criteria

• taking or planing to take any vitamin or mineral supplements during the study period
• pre-existing medical problems that might impact inflammation or Fe status, including malabsorption, blood disorders, ulcers, joint diseases and asthma
• taking any prescribed medications known to affect iron homeostasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Genotype at SNP rs9366637	2 weeks after the participant's visit to the laboratory	At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining genotype.
Serum transferrin receptor	Up to 6 months after the participant's visit to the laboratory	At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum transferrin receptor.
Hemoglobin	Up to 2 days after the participant's visit to the laboratory	At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of hemoglobin.
Serum Ferritin	Up to 6 months after the participant's visit to the laboratory	At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of serum ferritin.
Non-heme Iron absorption in women with 2 HFE genotypes	one month for screening with genotype then 2 weeks for iron absorption study	Women donated a blood sample for genotyping. Women with particular HFE genotypes were invited to return for an absorption study. Two weeks after women consume the iron tracer, a blood sample was obtained to measure the amount of iron absorbed.

Secondary Outcome Measures

Name	Time	Method
C-reactive protein	Up to 6 months after the participant's visit to the laboratory	At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of C-reactive protein.
Vitamin B-12	Up to 6 months after the participant's visit to the laboratory	At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of vitamin B-12.
Folate	Up to 6 months after the participant's visit to the laboratory	At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining the concentration of folate.

Trial Locations

Locations (1)

Human Metabolic Research Unit, Cornell University; 🇺🇸 Ithaca, New York, United States