- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02747316
Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status (PIANO)
April 21, 2021 updated by: 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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Zurich, Switzerland, 8092
- Human Nutrition Laboratory ETH Zurich
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isotopically labeled test meal week of pregnancy 20
|
test meal labeled with 12 mg 57Fe
|
Experimental: Isotopically labeled test meal week of pregnancy 30
|
test meal labeled with 12 mg 58Fe
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
week 20 of pregnancy
|
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
|
delivery
|
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.
|
week 30 of pregnancy
|
infants iron status
Time Frame: over the first six months of life
|
infants iron status
|
over the first six months of life
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Hepcidin
|
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 transferrin receptor
|
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 hemoglobin
|
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 c-reactive protein
|
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
|
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
Time Frame: 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
Time Frame: 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
Time Frame: 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
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
|
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
|
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
Time Frame: over the first 24 months of life
|
infants iron status
|
over the first 24 months of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
September 1, 2020
Study Registration Dates
First Submitted
January 8, 2016
First Submitted That Met QC Criteria
April 18, 2016
First Posted (Estimate)
April 21, 2016
Study Record Updates
Last Update Posted (Actual)
April 23, 2021
Last Update Submitted That Met QC Criteria
April 21, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIANO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Stable iron isotope 57 (57Fe) labeled iron solution
-
Swiss Federal Institute of TechnologyCompletedIron Deficiency AnemiaSwitzerland
-
GlaxoSmithKlineCompleted
-
Wageningen UniversitySwiss Federal Institute of Technology; Unilever R&D; Universidad de Monterrey; Mexican...Completed
-
National Institute of Diabetes and Digestive and...CompletedIron Deficiency AnemiaUnited States
-
Swiss Federal Institute of TechnologyWageningen University; Universidad de MonterreyCompleted
-
Swiss Federal Institute of TechnologyMahidol UniversityUnknownIron Deficiency Anemia of PregnancyThailand