- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02197624
Genetic Variants and Iron Absorption
21. juli 2014 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
57
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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Ithaca, New York, Forenede Stater, 14853
- Human Metabolic Research Unit, Cornell University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 35 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Genotype at SNP rs9366637
Tidsramme: 2 weeks after the participant's visit to the laboratory
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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
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Hemoglobin
Tidsramme: Up to 2 days after the participant's visit to the laboratory
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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
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Serum Ferritin
Tidsramme: Up to 6 months after the participant's visit to the laboratory
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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
Tidsramme: Up to 6 months after the participant's visit to the laboratory
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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
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Non-heme Iron absorption in women with 2 HFE genotypes
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Folate
Tidsramme: Up to 6 months after the participant's visit to the laboratory
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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
Tidsramme: Up to 6 months after the participant's visit to the laboratory
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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.
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Up to 6 months after the participant's visit to the laboratory
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C-reactive protein
Tidsramme: Up to 6 months after the participant's visit to the laboratory
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2012
Primær færdiggørelse (Faktiske)
1. april 2013
Studieafslutning (Faktiske)
1. maj 2014
Datoer for studieregistrering
Først indsendt
16. juli 2014
Først indsendt, der opfyldte QC-kriterier
21. juli 2014
Først opslået (Skøn)
23. juli 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. juli 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2014
Sidst verificeret
1. juli 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- IRB #: 1206003117
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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