NCT02747316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

3.2 years

First QC Date

January 8, 2016

Last Update Submit

April 21, 2021

Conditions

OverweightObesityPregnancy

Keywords

Iron bioavailabilityHepcidinIron absorption

Outcome Measures

Primary Outcomes (4)

  • 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.

    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

    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.

    week 30 of pregnancy

  • infants iron status

    infants iron status

    over the first six months of life

Secondary Outcomes (12)

  • Change in plasma ferritin

    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

    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

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

  • +7 more secondary outcomes

Study Arms (2)

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

Interventions

Stable iron isotope 57 (57Fe) labeled iron solutionOTHER

test meal labeled with 12 mg 57Fe

Isotopically labeled test meal week of pregnancy 20
Stable iron isotope 58 (58Fe) labeled iron solutionOTHER

test meal labeled with 12 mg 58Fe

Isotopically labeled test meal week of pregnancy 30

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • to 45 years old
  • singleton pregnancy
  • week of pregnancy 14±3

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Laboratory ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 34910118DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 8, 2016

First Posted

April 21, 2016

Study Start

February 1, 2016

Primary Completion

April 1, 2019

Study Completion

September 1, 2020

Last Updated

April 23, 2021

Record last verified: 2021-04

Locations

CH(1)