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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02747316
Acronym
PIANO
Enrollment
83
Registered
2016-04-21
Start date
2016-02-29
Completion date
2020-09-30
Last updated
2021-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight, Pregnancy

Keywords

Iron bioavailability, Hepcidin, Iron absorption

Brief summary

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.

Detailed description

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.

Interventions

OTHERStable iron isotope 57 (57Fe) labeled iron solution

test meal labeled with 12 mg 57Fe

OTHERStable iron isotope 58 (58Fe) labeled iron solution

test meal labeled with 12 mg 58Fe

Sponsors

Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fractional iron absorptionweek 20 of pregnancyThe 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.
iron transfer from the mother to the fetus in cord blood/infantdeliveryTo determine the amount of iron transferred from the mother to the fetus
infants iron statusover the first six months of lifeinfants iron status

Secondary

MeasureTime frameDescription
Change in hemoglobinweeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after deliveryChange in hemoglobin
Change in c-reactive proteinweeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after deliveryChange in c-reactive protein
Change in interleukin-6weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after deliveryChange in interleukin-6
Chage in alpha-1-acid glycoproteinweeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after deliveryChage in alpha-1-acid glycoprotein
Change in plasma ferritinweeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after deliveryChange in plasma ferritin
Change in riboflavinweeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after deliveryChange in riboflavin
Assessment of children's iron needs within their first 2 years of life using an isotope dilution techniqueFollow-up blood samples at 3, 6, 12, 18, 24 months after birthAssessment of children's iron needs within their first 2 years of life
Assessment of recovery of mother's iron Status after pregnancy using an isotope dilution techniqueFollow-up blood samples at 3, 6, 12, 18, 24 months after deliveryAssessment of recovery of mother's iron Status after pregnancy
infants iron statusover the first 24 months of lifeinfants iron status
Change in retinol binding proteinweeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after deliveryChange in retinol binding protein
Change in Hepcidinweeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after deliveryChange in Hepcidin
Change in transferrin receptorweeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after deliveryChange in transferrin receptor

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026