Iron Deficiency (ID) in Infants (CARMA)

Iron Deficiency in Infants : Population-wide Study of the Protective Role of Toddler Milk Formula

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency in Young Children Living in France
• Intervention / Treatment: Biological: Blood samples

Detailed Description

The general methodology planned is a nationwide observational cross-sectional study including a blood sample and nutritional survey. 100 pediatricians will include children from 21 regions different from a geographic and a dietary point of view. Each pediatrician will include 10 children consecutively including 3 with the french medical healthcare coverage called CMU (which is a precariousness marker).

The study will take place according to the following plan and procedures for each child: D1 recruitment in the physician-investigator's office (verification of inclusion criteria and collection of the first parent's consent, clinical data collection, prescription for blood test and delivery of the kit containing the elements needed for the study for the patients); between D8 and D15, performance of the standard laboratory tests to be performed locally in the medical laboratory normally used by the family, and the sending of samples for specific analyses (especially biochemistry) to reference laboratory that will perform all these analyses for this study; between D2 and D7, a 3-day food survey based on a food diary (see below); between D20 and D60, final study visit to the doctor's office (help in completing the food diary, discussion of the laboratory results, prescription of iron treatment if needed). The blood sample and/or the 3-days food survey will be delayed 15 days if any intercurrent disease which may interfere with biological markers or food intake (for example acute gastro-enteritis, fever) appears after D1 of inclusion.

• Study Type: Interventional
• Enrollment (Actual): 830
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Necker-Enfants Malades Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• chronic disease known at inclusion that might affect iron metabolism or reserves : blood transfusion since birth, celiac disease, chronic inflammatory disease, including of the intestines, cystic fibrosis, other enteropathy, enteral nutrition for more than 15 days in the past 6 months, chronic hemolytic diseases, chronic kidney disease, hemophilia, or chronic bleeding, such as ENT or gastrointestinal, hemochromatosis, any malignant condition, or lead poisoning)
• participation to another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: infants followed by pediatrician	Biological: Blood samples; 1 blood sample of 9 ml. 3-day food diary , according to the European Food Safety Authority methodology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemoglobin blood level	Iron-deficiency anemia determined by haemoglobin blood level < 11g/dl in infant with iron deficiency	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	Food diary	Between day 2 and day 7 (or plus 15 days)
Parents' economical and educational level		Day 1

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin; Association Clinique Thérapeutique Infantile du val de Marne; Association Française de Pédiatrie Ambulatoire- AFPA; CERBA; Laboratoire de Biochimie, CHU Louis Mourier; INSERM 1153, Centre de Recherche Epidémiologique et Biostatistique
• Investigators: Study Director: Martin Chalumeau, MD, PhD, INSERM UMR 1153

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2016
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimated): June 29, 2015

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: primary prevention; iron-deficiency anemia; iron-deficiency; population-based study; infants and toddlers; industrialised countries; prevalence and risk factors; screening strategies; diagnosis markers
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia, Iron-Deficiency; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: P140314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO