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Genetic Variants and Iron Absorption

21. juli 2014 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

57

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • New York
      • Ithaca, New York, Forente stater, 14853
        • Human Metabolic Research Unit, Cornell University

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 35 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Cornell University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2012

Primær fullføring (Faktiske)

1. april 2013

Studiet fullført (Faktiske)

1. mai 2014

Datoer for studieregistrering

Først innsendt

16. juli 2014

Først innsendt som oppfylte QC-kriteriene

21. juli 2014

Først lagt ut (Anslag)

23. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. juli 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2014

Sist bekreftet

1. juli 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • IRB #: 1206003117

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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