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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

83

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Isotopically labeled test meal week of pregnancy 20
Ander: Stable iron isotope 57 (57Fe) labeled iron solution
test meal labeled with 12 mg 57Fe
Experimenteel: Isotopically labeled test meal week of pregnancy 30
Ander: Stable iron isotope 58 (58Fe) labeled iron solution
test meal labeled with 12 mg 58Fe

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fractional iron absorption
Tijdsspanne: 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
Tijdsspanne: delivery
To determine the amount of iron transferred from the mother to the fetus
delivery
Fractional iron absorption
Tijdsspanne: 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
Tijdsspanne: over the first six months of life
infants iron status
over the first six months of life

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in plasma ferritin
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: over the first 24 months of life
infants iron status
over the first 24 months of life

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Swiss Federal Institute of Technology

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 februari 2016

Primaire voltooiing (Werkelijk)

1 april 2019

Studie voltooiing (Werkelijk)

1 september 2020

Studieregistratiedata

Eerst ingediend

8 januari 2016

Eerst ingediend dat voldeed aan de QC-criteria

18 april 2016

Eerst geplaatst (Schatting)

21 april 2016

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 april 2021

Laatste update ingediend die voldeed aan QC-criteria

21 april 2021

Laatst geverifieerd

1 april 2021

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PIANO

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