Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status (PIANO)
Primary Purpose
Overweight, Obesity, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Stable iron isotope 57 (57Fe) labeled iron solution
Stable iron isotope 58 (58Fe) labeled iron solution
Sponsored by

About this trial
This is an interventional basic science trial for Overweight focused on measuring Iron bioavailability, Hepcidin, Iron absorption
Eligibility Criteria
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
Sites / Locations
- Human Nutrition Laboratory ETH Zurich
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Isotopically labeled test meal week of pregnancy 20
Isotopically labeled test meal week of pregnancy 30
Arm Description
Outcomes
Primary Outcome Measures
Fractional iron absorption
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.
iron transfer from the mother to the fetus in cord blood/infant
To determine the amount of iron transferred from the mother to the fetus
Fractional iron absorption
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.
infants iron status
infants iron status
Secondary Outcome Measures
Change in plasma ferritin
Change in plasma ferritin
Change in Hepcidin
Change in Hepcidin
Change in transferrin receptor
Change in transferrin receptor
Change in hemoglobin
Change in hemoglobin
Change in c-reactive protein
Change in c-reactive protein
Change in interleukin-6
Change in interleukin-6
Chage in alpha-1-acid glycoprotein
Chage in alpha-1-acid glycoprotein
Change in retinol binding protein
Change in retinol binding protein
Change in riboflavin
Change in riboflavin
Assessment of children's iron needs within their first 2 years of life using an isotope dilution technique
Assessment 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 technique
Assessment of recovery of mother's iron Status after pregnancy
infants iron status
infants iron status
Full Information
NCT ID
NCT02747316
First Posted
January 8, 2016
Last Updated
April 21, 2021
Sponsor
Swiss Federal Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT02747316
Brief Title
Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status
Acronym
PIANO
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
September 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Pregnancy
Keywords
Iron bioavailability, Hepcidin, Iron absorption
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isotopically labeled test meal week of pregnancy 20
Arm Type
Experimental
Arm Title
Isotopically labeled test meal week of pregnancy 30
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Stable iron isotope 57 (57Fe) labeled iron solution
Intervention Description
test meal labeled with 12 mg 57Fe
Intervention Type
Other
Intervention Name(s)
Stable iron isotope 58 (58Fe) labeled iron solution
Intervention Description
test meal labeled with 12 mg 58Fe
Primary Outcome Measure Information:
Title
Fractional iron absorption
Description
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.
Time Frame
week 20 of pregnancy
Title
iron transfer from the mother to the fetus in cord blood/infant
Description
To determine the amount of iron transferred from the mother to the fetus
Time Frame
delivery
Title
Fractional iron absorption
Description
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.
Time Frame
week 30 of pregnancy
Title
infants iron status
Description
infants iron status
Time Frame
over the first six months of life
Secondary Outcome Measure Information:
Title
Change in plasma ferritin
Description
Change in plasma ferritin
Time Frame
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Title
Change in Hepcidin
Description
Change in Hepcidin
Time Frame
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Title
Change in transferrin receptor
Description
Change in transferrin receptor
Time Frame
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Title
Change in hemoglobin
Description
Change in hemoglobin
Time Frame
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Title
Change in c-reactive protein
Description
Change in c-reactive protein
Time Frame
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Title
Change in interleukin-6
Description
Change in interleukin-6
Time Frame
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Title
Chage in alpha-1-acid glycoprotein
Description
Chage in alpha-1-acid glycoprotein
Time Frame
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Title
Change in retinol binding protein
Description
Change in retinol binding protein
Time Frame
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Title
Change in riboflavin
Description
Change in riboflavin
Time Frame
weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Title
Assessment of children's iron needs within their first 2 years of life using an isotope dilution technique
Description
Assessment of children's iron needs within their first 2 years of life
Time Frame
Follow-up blood samples at 3, 6, 12, 18, 24 months after birth
Title
Assessment of recovery of mother's iron Status after pregnancy using an isotope dilution technique
Description
Assessment of recovery of mother's iron Status after pregnancy
Time Frame
Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery
Title
infants iron status
Description
infants iron status
Time Frame
over the first 24 months of life
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Human Nutrition Laboratory ETH Zurich
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
34910118
Citation
Stoffel NU, Zimmermann MB, Cepeda-Lopez AC, Cervantes-Gracia K, Llanas-Cornejo D, Zeder C, Tuntipopipat S, Moungmaithong S, Densupsoontorn N, Quack Loetscher K, Gowachirapant S, Herter-Aeberli I. Maternal iron kinetics and maternal-fetal iron transfer in normal-weight and overweight pregnancy. Am J Clin Nutr. 2022 Apr 1;115(4):1166-1179. doi: 10.1093/ajcn/nqab406.
Results Reference
derived
Learn more about this trial
Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status
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