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| Name | Class |
|---|---|
| Association Clinique Thérapeutique Infantile du val de Marne | OTHER |
| Association Française de Pédiatrie Ambulatoire- AFPA | UNKNOWN |
| CERBA | UNKNOWN |
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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 :
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| infants followed by pediatrician | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Biological | 1 blood sample of 9 ml. 3-day food diary , according to the European Food Safety Authority methodology |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Chalumeau, MD, PhD | INSERM UMR 1153 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Necker-Enfants Malades hospital | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20923825 | Background | 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. | |
| 24135983 | Background | 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. |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Laboratoire de Biochimie, CHU Louis Mourier |
| UNKNOWN |
| INSERM 1153, Centre de Recherche Epidémiologique et Biostatistique | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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| 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 |
| 23098567 | Background | 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. |
| 32507584 | Result | 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. |
| 29228047 | Result | 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. |
| 33836187 | Derived | 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. |
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |