Genetic Variants and Iron Absorption

NCT ID: NCT02197624

Last Updated: 2014-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-05-31

Brief Summary

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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

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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.

Conditions

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Iron Absorption

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly O'Brien, PhD

Role: PRINCIPAL_INVESTIGATOR

Cornell University

Locations

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Human Metabolic Research Unit, Cornell University

Ithaca, New York, United States

Site Status

Countries

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United States

Other Identifiers

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IRB #: 1206003117

Identifier Type: -

Identifier Source: org_study_id

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