- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02197624
Genetic Variants and Iron Absorption
21 luglio 2014 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
57
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New York
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Ithaca, New York, Stati Uniti, 14853
- Human Metabolic Research Unit, Cornell University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 35 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Femmina
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
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.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Genotype at SNP rs9366637
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Folate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2012
Completamento primario (Effettivo)
1 aprile 2013
Completamento dello studio (Effettivo)
1 maggio 2014
Date di iscrizione allo studio
Primo inviato
16 luglio 2014
Primo inviato che soddisfa i criteri di controllo qualità
21 luglio 2014
Primo Inserito (Stima)
23 luglio 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
23 luglio 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 luglio 2014
Ultimo verificato
1 luglio 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- IRB #: 1206003117
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .