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 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
83
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Zurich, Schweiz, 8092
- Human Nutrition Laboratory ETH Zurich
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Isotopically labeled test meal week of pregnancy 20
|
test meal labeled with 12 mg 57Fe
|
|
Experimentell: Isotopically labeled test meal week of pregnancy 30
|
test meal labeled with 12 mg 58Fe
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fractional iron absorption
Tidsram: 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
Tidsram: delivery
|
To determine the amount of iron transferred from the mother to the fetus
|
delivery
|
|
Fractional iron absorption
Tidsram: 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
Tidsram: over the first six months of life
|
infants iron status
|
over the first six months of life
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in plasma ferritin
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: over the first 24 months of life
|
infants iron status
|
over the first 24 months of life
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2016
Primärt slutförande (Faktisk)
1 april 2019
Avslutad studie (Faktisk)
1 september 2020
Studieregistreringsdatum
Först inskickad
8 januari 2016
Först inskickad som uppfyllde QC-kriterierna
18 april 2016
Första postat (Uppskatta)
21 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 april 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 april 2021
Senast verifierad
1 april 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PIANO
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Fetma
-
SanionaAvslutadHypothalamic Injury-induced Obesity (HIO)Danmark