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- Essai clinique NCT02197624
Genetic Variants and Iron Absorption
21 juillet 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
57
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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Ithaca, New York, États-Unis, 14853
- Human Metabolic Research Unit, Cornell University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 35 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Femelle
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Genotype at SNP rs9366637
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Folate
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2012
Achèvement primaire (Réel)
1 avril 2013
Achèvement de l'étude (Réel)
1 mai 2014
Dates d'inscription aux études
Première soumission
16 juillet 2014
Première soumission répondant aux critères de contrôle qualité
21 juillet 2014
Première publication (Estimation)
23 juillet 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
23 juillet 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 juillet 2014
Dernière vérification
1 juillet 2014
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB #: 1206003117
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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