- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02484274
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.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
-
Paris, Frankreich, 75015
- Necker-Enfants Malades Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Sonstiges: infants followed by pediatrician
|
1 blood sample of 9 ml.
3-day food diary , according to the European Food Safety Authority methodology
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Serum ferritin level
Zeitfenster: Between day 8 and day 15 (or plus 15 days)
|
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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Haemoglobin blood level
Zeitfenster: Between day 8 and day 15 (or plus 15 days)
|
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)
Zeitfenster: Between day 8 and day 15 (or plus 15 days)
|
Between day 8 and day 15 (or plus 15 days)
|
|
Iron intake related to toddler milk formula
Zeitfenster: Between day 2 and day 7 (or plus 15 days)
|
Food diary
|
Between day 2 and day 7 (or plus 15 days)
|
Parents' economical and educational level
Zeitfenster: Day 1
|
Day 1
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienleiter: Martin Chalumeau, MD, PhD, INSERM UMR 1153
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P140314
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Blood samples
-
Hillel Yaffe Medical CenterUnbekannt
-
Cerus CorporationRekrutierungAnämieVereinigte Staaten, Puerto Rico
-
University Hospital, RouenNoch keine RekrutierungHepatitis B | Hepatitis C | AIDSFrankreich
-
Haydarpasa Numune Training and Research HospitalAbgeschlossenBlutgerinnungsstörungTruthahn
-
George Fox UniversityUnbekanntMuskelschwäche | Kann eine Therapie zur Einschränkung des Blutflusses den Kraftzuwachs in der Rotatorenmanschette steigern?Vereinigte Staaten
-
HemanextAbgeschlossenVollblutspende und LeukoreduktionVereinigte Staaten
-
University of UtahAlbert Einstein College of Medicine; University of California, San Francisco; National... und andere MitarbeiterAbgeschlossen
-
Ischemia Care LLCAbgeschlossenIschämischer Schlaganfall | Vorhofflimmern | Thrombotischer Schlaganfall | Transiente ischämische Attacken | Kardioembolischer Schlaganfall | Schlaganfall der Arteria basilaris | Vorübergehende zerebrovaskuläre EreignisseVereinigte Staaten
-
ANRS, Emerging Infectious DiseasesInstitute of Research for Development, FranceAbgeschlossen
-
Centre Hospitalier Princesse GraceAbgeschlossen