Genetic Variants and Iron Absorption

Iron Absorption Clinical Trial

Official title:

Metabolic Adaptation to Plant-based Diets in Asian Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197624
• Other study ID #: IRB #: 1206003117
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: July 21, 2014
• Start date: June 2012
• Est. completion date: May 2014

Study information

• Verified date: July 2014
• Source: Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Iron Absorption

Locations

Country	Name	City	State
United States	Human Metabolic Research Unit, Cornell University	Ithaca	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genotype at SNP rs9366637	At the participant's visit to the laboratory, a 10 mL blood sample was collected. The blood sample was used for determining genotype.	2 weeks after the participant's visit to the laboratory	No
Primary	Hemoglobin	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.	Up to 2 days after the participant's visit to the laboratory	No
Primary	Serum Ferritin	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.	Up to 6 months after the participant's visit to the laboratory	No
Primary	Serum transferrin receptor	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.	Up to 6 months after the participant's visit to the laboratory	No
Primary	Non-heme Iron absorption in women with 2 HFE genotypes	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.	one month for screening with genotype then 2 weeks for iron absorption study	No
Secondary	Folate	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.	Up to 6 months after the participant's visit to the laboratory	No
Secondary	Vitamin B-12	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.	Up to 6 months after the participant's visit to the laboratory	No
Secondary	C-reactive protein	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.	Up to 6 months after the participant's visit to the laboratory	No