Iron Deficiency (ID) in Infants
Condition: Iron Deficiency in Young Children Living in France
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

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.
    

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.
    

Intervention name(s): Blood samples
Intervention type(s): Biological
Intervention description(s): 1 blood sample of 9 ml. 3-day food diary , according to the European Food Safety Authority methodology
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: iron-deficiency; iron-deficiency anemia; infants and toddlers; industrialised countries; population-based study; prevalence and risk factors; screening strategies; diagnosis markers; primary prevention