Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status (PIANO)
21 avril 2021 mis à jour par: Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
Maternal Iron Absorption and Utilization and Iron Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infant Iron Status
Overweight and obesity causes low-grade systemic inflammation, which sharply increases risk for iron deficiency.
Studies in our laboratory have shown that this is mainly the result of reduced dietary iron absorption because of increased hepcidin concentrations.
During pregnancy, women have a large increase in iron needs because of the expansion of maternal blood volume and fetal needs.
Iron deficiency anemia in infancy can impair cognitive development.
Whether maternal adiposity impairs absorption and transfer of iron to the fetus, and thereby increases risk of iron deficiency in the mother and the infant is unclear.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
In obese subjects, hepcidin concentrations are increased and iron absorption is believed to be reduced, leading to iron deficiency over time.
How all this will influence iron supply of the fetus in obese pregnancy has not been well investigated to date.
Even if maternal and fetal iron uptakes are regulated separately, it is unclear to what extent maternal subclinical inflammation might influence this process.
A small study by Dao et al. indicated that maternal-fetal iron transfer was impaired in obese pregnant women, possibly due to hepcidin up-regulation.
In this study, both maternal BMI as well as hepcidin were negatively correlated with cord blood iron status.
Maternal hepcidin and c-reactive protein were significantly higher and cord blood iron was significantly lower in the obese compared to the normal weight.
Hepcidin was shown to have an effect on iron transfer across the placenta in the study by Young et al.: the transfer was increased in women with undetectable hepcidin at delivery compared to those with higher levels.
As of now, clear associations between maternal BMI or maternal hepcidin concentration and fetal iron status were not shown.
Type d'étude
Interventionnel
Inscription (Réel)
83
Phase
- N'est pas applicable
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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Zurich, Suisse, 8092
- Human Nutrition Laboratory ETH Zurich
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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 45 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
Inclusion Criteria:
- Pregnant women with either normal pre-pregnancy BMI (BMI 18.5 - 24.9kg/kg2) or with overweight or obesity (BMI > 27.5kg/m2) before pregnancy (assessed based on data reported by the women at their first visit at the hospital)
- 18 to 45 years old
- singleton pregnancy
- week of pregnancy 14±3
Exclusion Criteria:
- underlying malabsorption disease
- chronic illness, which influences iron absorption
- inflammatory status other than obesity
- medical problems known to affect iron homeostasis
- smoking during pregnancy
- no regular use of medication, which influences iron absorption
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
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Isotopically labeled test meal week of pregnancy 20
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test meal labeled with 12 mg 57Fe
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Expérimental: Isotopically labeled test meal week of pregnancy 30
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test meal labeled with 12 mg 58Fe
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fractional iron absorption
Délai: week 20 of pregnancy
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The fractional iron absorption from the first test meal will be calculated based on the shift of the iron isotopic ratios in the collected blood samples 14 days after administration of the isotopically labeled meal.
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week 20 of pregnancy
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iron transfer from the mother to the fetus in cord blood/infant
Délai: delivery
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To determine the amount of iron transferred from the mother to the fetus
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delivery
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Fractional iron absorption
Délai: week 30 of pregnancy
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The fractional iron absorption from the second test meal will be calculated based on the shift of the iron isotopic ratios in the collected blood samples 14 days after administration of the isotopically labeled meal.
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week 30 of pregnancy
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infants iron status
Délai: over the first six months of life
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infants iron status
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over the first six months of life
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in plasma ferritin
Délai: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in plasma ferritin
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in Hepcidin
Délai: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in Hepcidin
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in transferrin receptor
Délai: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in transferrin receptor
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in hemoglobin
Délai: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in hemoglobin
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in c-reactive protein
Délai: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in c-reactive protein
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in interleukin-6
Délai: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in interleukin-6
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Chage in alpha-1-acid glycoprotein
Délai: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Chage in alpha-1-acid glycoprotein
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in retinol binding protein
Délai: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in retinol binding protein
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in riboflavin
Délai: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Change in riboflavin
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weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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Assessment of children's iron needs within their first 2 years of life using an isotope dilution technique
Délai: Follow-up blood samples at 3, 6, 12, 18, 24 months after birth
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Assessment of children's iron needs within their first 2 years of life
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Follow-up blood samples at 3, 6, 12, 18, 24 months after birth
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Assessment of recovery of mother's iron Status after pregnancy using an isotope dilution technique
Délai: Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery
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Assessment of recovery of mother's iron Status after pregnancy
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Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery
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infants iron status
Délai: over the first 24 months of life
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infants iron status
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over the first 24 months of life
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Collaborateurs et enquêteurs
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Publications et liens utiles
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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 (Réel)
1 février 2016
Achèvement primaire (Réel)
1 avril 2019
Achèvement de l'étude (Réel)
1 septembre 2020
Dates d'inscription aux études
Première soumission
8 janvier 2016
Première soumission répondant aux critères de contrôle qualité
18 avril 2016
Première publication (Estimation)
21 avril 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 avril 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 avril 2021
Dernière vérification
1 avril 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PIANO
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