NCT02484274

Brief Summary

ID in children is the most frequent micronutrient deficiency in industrialized countries, including France. ID induces neurological impairment reducing cognitive, motor, and behavioral capacities in children in the short and long term. The purpose of this study is to evaluate the principal determinants of ID in France in two-year-old children and to improve strategies for prevention and screening. The main objective is to study the association between iron status in two-year-old infants living in France and the consumption of toddler milk formula after taking non-dairy iron ingestion, parental socioeconomic status and educational level into account. The secondary objectives are the following :

  • to estimate the prevalence of ID and ID anemia in 2-year-old children living in France.
  • to improve clinical tools for ID screening. to improve strategies for laboratory screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
830

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration 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

June 25, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

January 6, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

June 25, 2015

Last Update Submit

March 2, 2026

Conditions

Iron Deficiency in Young Children Living in France

Keywords

iron-deficiencyiron-deficiency anemiainfants and toddlersindustrialised countriespopulation-based studyprevalence and risk factorsscreening strategiesdiagnosis markersprimary prevention

Outcome Measures

Primary Outcomes (1)

  • Serum ferritin level

    Iron deficiency determined by serum ferritin level \< 10 µg/l with C Reactive Protein (CRP) \< 5 mg/l

    Between day 8 and day 15 (or plus 15 days)

Secondary Outcomes (4)

  • Haemoglobin blood level

    Between day 8 and day 15 (or plus 15 days)

  • Dosage of biochemical markers (hepcidin, erythrocytic protoporphyrin)

    Between day 8 and day 15 (or plus 15 days)

  • Iron intake related to toddler milk formula

    Between day 2 and day 7 (or plus 15 days)

  • Parents' economical and educational level

    Day 1

Study Arms (1)

infants followed by pediatrician

OTHER
Biological: Blood samples

Interventions

Blood samplesBIOLOGICAL

1 blood sample of 9 ml. 3-day food diary , according to the European Food Safety Authority methodology

infants followed by pediatrician

Eligibility Criteria

Age22 Months - 26 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants aged 22-26 months
  • living usually in France
  • written agreement of one parent or the holder of parental authority
  • followed-up by a liberal paediatrician
  • with social coverage

You may not qualify if:

  • participation to another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker-Enfants Malades hospital

Paris, 75015, France

Location

Related Publications (6)

  • Baker RD, Greer FR; Committee on Nutrition American Academy of Pediatrics. Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age). Pediatrics. 2010 Nov;126(5):1040-50. doi: 10.1542/peds.2010-2576. Epub 2010 Oct 5.

    PMID: 20923825BACKGROUND

  • Domellof M, Braegger C, Campoy C, Colomb V, Decsi T, Fewtrell M, Hojsak I, Mihatsch W, Molgaard C, Shamir R, Turck D, van Goudoever J; ESPGHAN Committee on Nutrition. Iron requirements of infants and toddlers. J Pediatr Gastroenterol Nutr. 2014 Jan;58(1):119-29. doi: 10.1097/MPG.0000000000000206.

    PMID: 24135983BACKGROUND

  • Ghisolfi J, Fantino M, Turck D, de Courcy GP, Vidailhet M. Nutrient intakes of children aged 1-2 years as a function of milk consumption, cows' milk or growing-up milk. Public Health Nutr. 2013 Mar;16(3):524-34. doi: 10.1017/S1368980012002893. Epub 2012 Jul 4.

    PMID: 23098567BACKGROUND

  • Sacri AS, Bocquet A, de Montalembert M, Hercberg S, Gouya L, Blondel B, Ganon A, Hebel P, Vincelet C, Thollot F, Rallo M, Gembara P, Levy C, Chalumeau M. Young children formula consumption and iron deficiency at 24 months in the general population: A national-level study. Clin Nutr. 2021 Jan;40(1):166-173. doi: 10.1016/j.clnu.2020.04.041. Epub 2020 May 7.

    PMID: 32507584RESULT

  • Sacri AS, Ferreira D, Khoshnood B, Gouya L, Barros H, Chalumeau M. Stability of serum ferritin measured by immunoturbidimetric assay after storage at -80 degrees C for several years. PLoS One. 2017 Dec 11;12(12):e0188332. doi: 10.1371/journal.pone.0188332. eCollection 2017.

    PMID: 29228047RESULT

  • Guivarch C, Sacri AS, Levy C, Bocquet A, Lapidus N, Hercberg S, Hebel P, Cheve A, Copin C, Zouari M, Gouya L, de Montalembert M, Cohen JF, Chalumeau M. Clinical Prediction of Iron Deficiency at Age 2 Years: A National Cross-sectional Study in France. J Pediatr. 2021 Aug;235:212-219. doi: 10.1016/j.jpeds.2021.03.072. Epub 2021 Apr 6.

    PMID: 33836187DERIVED

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Martin Chalumeau, MD, PhD

    INSERM UMR 1153

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

June 29, 2015

Study Start

January 6, 2016

Primary Completion

January 15, 2018

Study Completion

May 1, 2018

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)