- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02197624
Genetic Variants and Iron Absorption
July 21, 2014 updated by: Cornell University
Metabolic Adaptation to Plant-based Diets in Asian Populations
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
57
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Ithaca, New York, United States, 14853
- Human Metabolic Research Unit, Cornell University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women were eligible for the study if they met the following criteria: 1) non-pregnant and between the ages of 18~35 y; 2) of East Asian descent with both maternal and paternal grandparents from East Asia, including China, Japan, South Korea, Vietnam, Thailand, Malaysia and Singapore; 3) not taking any vitamin or mineral supplements for at least 1 month before the study and during the 2-week study interval; 4) no pre-existing medical problems including malabsorption, blood disorders, ulcers, joint diseases or asthma that might impact inflammation or Fe status; 5) not taking any prescribed medications known to affect iron homeostasis.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Genotype at SNP rs9366637
Time Frame: 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.
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2 weeks after the participant's visit to the laboratory
|
Hemoglobin
Time Frame: 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.
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Up to 2 days after the participant's visit to the laboratory
|
Serum Ferritin
Time Frame: 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.
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Up to 6 months after the participant's visit to the laboratory
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Serum transferrin receptor
Time Frame: 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.
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Up to 6 months after the participant's visit to the laboratory
|
Non-heme Iron absorption in women with 2 HFE genotypes
Time Frame: one month for screening with genotype then 2 weeks for iron absorption study
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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.
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one month for screening with genotype then 2 weeks for iron absorption study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Folate
Time Frame: 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.
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Up to 6 months after the participant's visit to the laboratory
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Vitamin B-12
Time Frame: 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.
|
Up to 6 months after the participant's visit to the laboratory
|
C-reactive protein
Time Frame: 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.
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Up to 6 months after the participant's visit to the laboratory
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
July 16, 2014
First Submitted That Met QC Criteria
July 21, 2014
First Posted (Estimate)
July 23, 2014
Study Record Updates
Last Update Posted (Estimate)
July 23, 2014
Last Update Submitted That Met QC Criteria
July 21, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB #: 1206003117
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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