OverweightPIANONCT02747316
Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status
A study testing Stable iron isotope 57 (57Fe) labeled iron solution and Stable iron isotope 58 (58Fe) labeled iron solution in people with Overweight and Obesity, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Overweight, Obesity, Pregnancy
- What is being tested?
- Stable iron isotope 57 (57Fe) labeled iron solution and Stable iron isotope 58 (58Fe) labeled iron solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Overweight, Obesity, Pregnancy
- Being tested
- Stable iron isotope 57 (57Fe) labeled iron solution, Stable iron isotope 58 (58Fe) labeled iron solution
- Keywords
- Iron bioavailability, Hepcidin, Iron absorption
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stable iron isotope 57 (57Fe) labeled iron solutionOther
test meal labeled with 12 mg 57Fe
Stable iron isotope 58 (58Fe) labeled iron solutionOther
test meal labeled with 12 mg 58Fe
| Study group | Role | What they receive |
|---|---|---|
| Isotopically labeled test meal week of pregnancy 20 | Experimental | Not described Receives: Other: Stable iron isotope 57 (57Fe) labeled iron solution |
| Isotopically labeled test meal week of pregnancy 30 | Experimental | Not described Receives: Other: Stable iron isotope 58 (58Fe) labeled iron solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: week 20 of pregnancy
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
Measured: delivery
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.
Measured: week 30 of pregnancy
infants iron status
infants iron status
Measured: over the first six months of life
Secondary outcomes (12)
Change in plasma ferritin
Change in plasma ferritin
Measured: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in Hepcidin
Change in Hepcidin
Measured: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in transferrin receptor
Change in transferrin receptor
Measured: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in hemoglobin
Change in hemoglobin
Measured: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in c-reactive protein
Change in c-reactive protein
Measured: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in interleukin-6
Change in interleukin-6
Measured: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Chage in alpha-1-acid glycoprotein
Chage in alpha-1-acid glycoprotein
Measured: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in retinol binding protein
Change in retinol binding protein
Measured: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in riboflavin
Change in riboflavin
Measured: 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
Assessment of children's iron needs within their first 2 years of life
Measured: 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
Assessment of recovery of mother's iron Status after pregnancy
Measured: Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery
infants iron status
infants iron status
Measured: over the first 24 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2019
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Herter-Aeberli, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747316
- Sponsor's protocol ID
- PIANO
- Acronym
- PIANO
- Status last verified
- Apr 2021
- First submitted
- 8 Jan 2016
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34910118
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02747316
- Acronym / sponsor ID
- PIANO / PIANO
- Conditions
- Overweight, Obesity, Pregnancy
- Keywords
- Iron bioavailability, Hepcidin, Iron absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotopically labeled test meal week of pregnancy 20 | Experimental | Other: Stable iron isotope 57 (57Fe) labeled iron solution |
| Isotopically labeled test meal week of pregnancy 30 | Experimental | Other: Stable iron isotope 58 (58Fe) labeled iron solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- underlying malabsorption disease
- chronic illness, which influences iron absorption
- inflammatory status other than obesity
- medical problems known to affect iron homeostasis
- smoking during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stable iron isotope 57 (57Fe) labeled iron solutiontest meal labeled with 12 mg 57Fe | Other | Isotopically labeled test meal week of pregnancy 20 |
| Stable iron isotope 58 (58Fe) labeled iron solutiontest meal labeled with 12 mg 58Fe | Other | Isotopically labeled test meal week of pregnancy 30 |
Primary outcome
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.
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
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.
infants iron status
Time frame: over the first six months of life
infants iron status
12 secondary outcomes
Change in plasma ferritin
Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in Hepcidin
Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in transferrin receptor
Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in hemoglobin
Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in c-reactive protein
Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in interleukin-6
Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Chage in alpha-1-acid glycoprotein
Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in retinol binding protein
Time frame: weeks of pregnancy 12, 18, 20, 28, 30, 36; 3 and 6 months after delivery
Change in riboflavin
Time frame: 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
Time frame: 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
Time frame: Follow-up blood samples at 3, 6, 12, 18, 24 months after delivery
infants iron status
Time frame: over the first 24 months of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Derived from this study: PubMed 34910118Stoffel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stable iron isotope 57 (57Fe) labeled iron solution and Stable iron isotope 58 (58Fe) labeled iron solution in people with Overweight and Obesity, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional iron absorption (time frame: week 20 of pregnancy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02747316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.