- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02747316
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. April 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
83
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Zurich, Schweiz, 8092
- Human Nutrition Laboratory ETH Zurich
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 45 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Isotopically labeled test meal week of pregnancy 20
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test meal labeled with 12 mg 57Fe
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Experimental: Isotopically labeled test meal week of pregnancy 30
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test meal labeled with 12 mg 58Fe
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Fractional iron absorption
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in plasma ferritin
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
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Publikationen und hilfreiche Links
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Studienaufzeichnungsdaten
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Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Februar 2016
Primärer Abschluss (Tatsächlich)
1. April 2019
Studienabschluss (Tatsächlich)
1. September 2020
Studienanmeldedaten
Zuerst eingereicht
8. Januar 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
18. April 2016
Zuerst gepostet (Schätzen)
21. April 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
23. April 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. April 2021
Zuletzt verifiziert
1. April 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PIANO
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