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Completed

NCT Number: NCT02747316

Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Laboratory ETH Zurich

Zurich, 8092, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stable iron isotope 57 (57Fe) labeled iron solution

Other

test meal labeled with 12 mg 57Fe

Stable iron isotope 58 (58Fe) labeled iron solution

Other

test meal labeled with 12 mg 58Fe

Primary outcomes

  1. Fractional iron absorption

    Time frame: 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.

  2. iron transfer from the mother to the fetus in cord blood/infant

    Time frame: delivery

    To determine the amount of iron transferred from the mother to the fetus

  3. Fractional iron absorption

    Time frame: 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.

  4. infants iron status

    Time frame: over the first six months of life

    infants iron status

Secondary outcomes

  1. Change in plasma ferritin

    Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery

    Change in plasma ferritin

  2. Change in Hepcidin

    Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery

    Change in Hepcidin

  3. Change in transferrin receptor

    Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery

    Change in transferrin receptor

  4. Change in hemoglobin

    Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery

    Change in hemoglobin

  5. Change in c-reactive protein

    Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery

    Change in c-reactive protein

  6. Change in interleukin-6

    Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery

    Change in interleukin-6

  7. Chage in alpha-1-acid glycoprotein

    Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery

    Chage in alpha-1-acid glycoprotein

  8. Change in retinol binding protein

    Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery

    Change in retinol binding protein

  9. Change in riboflavin

    Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery

    Change in riboflavin

  10. Assessment of children's iron needs within their first 2 years of life using an isotope dilution technique

    Time frame: 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

  11. Assessment of recovery of mother's iron Status after pregnancy using an isotope dilution technique

    Time frame: Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery

    Assessment of recovery of mother's iron Status after pregnancy

  12. infants iron status

    Time frame: over the first 24 months of life

    infants iron status

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

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

Acronym: PIANO

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 21, 2016
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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