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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

    • New York
      • Ithaca, New York, Forenede Stater, 14853
        • Human Metabolic Research Unit, Cornell University

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
Genotype at SNP rs9366637
Tidsramme: 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.
2 weeks after the participant's visit to the laboratory
Hemoglobin
Tidsramme: 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.
Up to 2 days after the participant's visit to the laboratory
Serum Ferritin
Tidsramme: 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.
Up to 6 months after the participant's visit to the laboratory
Serum transferrin receptor
Tidsramme: 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.
Up to 6 months after the participant's visit to the laboratory
Non-heme Iron absorption in women with 2 HFE genotypes
Tidsramme: 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.
one month for screening with genotype then 2 weeks for iron absorption study

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Folate
Tidsramme: 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.
Up to 6 months after the participant's visit to the laboratory
Vitamin B-12
Tidsramme: 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
Tidsramme: 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.
Up to 6 months after the participant's visit to the laboratory

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

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 .

Kliniske forsøg med Jernoptagelse

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