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 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
83
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Zurich, Schweiz, 8092
- Human Nutrition Laboratory ETH Zurich
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 45 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Isotopically labeled test meal week of pregnancy 20
|
test meal labeled with 12 mg 57Fe
|
|
Eksperimentel: Isotopically labeled test meal week of pregnancy 30
|
test meal labeled with 12 mg 58Fe
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fractional iron absorption
Tidsramme: 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
Tidsramme: delivery
|
To determine the amount of iron transferred from the mother to the fetus
|
delivery
|
|
Fractional iron absorption
Tidsramme: 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
Tidsramme: over the first six months of life
|
infants iron status
|
over the first six months of life
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in plasma ferritin
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: over the first 24 months of life
|
infants iron status
|
over the first 24 months of life
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. februar 2016
Primær færdiggørelse (Faktiske)
1. april 2019
Studieafslutning (Faktiske)
1. september 2020
Datoer for studieregistrering
Først indsendt
8. januar 2016
Først indsendt, der opfyldte QC-kriterier
18. april 2016
Først opslået (Skøn)
21. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PIANO
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .