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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

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

      • Zurich, Schweiz, 8092
        • Human Nutrition Laboratory ETH Zurich

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
Experimental: Isotopically labeled test meal week of pregnancy 20
test meal labeled with 12 mg 57Fe
Experimental: Isotopically labeled test meal week of pregnancy 30
test meal labeled with 12 mg 58Fe

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Fractional iron absorption
Zeitfenster: week 20 of pregnancy
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.
week 20 of pregnancy
iron transfer from the mother to the fetus in cord blood/infant
Zeitfenster: delivery
To determine the amount of iron transferred from the mother to the fetus
delivery
Fractional iron absorption
Zeitfenster: week 30 of pregnancy
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.
week 30 of pregnancy
infants iron status
Zeitfenster: over the first six months of life
infants iron status
over the first six months of life

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in plasma ferritin
Zeitfenster: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in plasma ferritin
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in Hepcidin
Zeitfenster: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in Hepcidin
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in transferrin receptor
Zeitfenster: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in transferrin receptor
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in hemoglobin
Zeitfenster: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in hemoglobin
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in c-reactive protein
Zeitfenster: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in c-reactive protein
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in interleukin-6
Zeitfenster: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in interleukin-6
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Chage in alpha-1-acid glycoprotein
Zeitfenster: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Chage in alpha-1-acid glycoprotein
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in retinol binding protein
Zeitfenster: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in retinol binding protein
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in riboflavin
Zeitfenster: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in riboflavin
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
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
Assessment of children's iron needs within their first 2 years of life
Follow-up blood samples at 3, 6, 12, 18, 24 months after birth
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
Assessment of recovery of mother's iron Status after pregnancy
Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery
infants iron status
Zeitfenster: over the first 24 months of life
infants iron status
over the first 24 months of life

Mitarbeiter und Ermittler

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Publikationen und hilfreiche Links

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Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

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

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