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Genetic Variants and Iron Absorption

21 juli 2014 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

57

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • New York
      • Ithaca, New York, Verenigde Staten, 14853
        • Human Metabolic Research Unit, Cornell University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 35 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Genotype at SNP rs9366637
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Folate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2012

Primaire voltooiing (Werkelijk)

1 april 2013

Studie voltooiing (Werkelijk)

1 mei 2014

Studieregistratiedata

Eerst ingediend

16 juli 2014

Eerst ingediend dat voldeed aan de QC-criteria

21 juli 2014

Eerst geplaatst (Schatting)

23 juli 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

23 juli 2014

Laatste update ingediend die voldeed aan QC-criteria

21 juli 2014

Laatst geverifieerd

1 juli 2014

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • IRB #: 1206003117

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op IJzer Absorptie

3
Abonneren