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Iron Deficiency (ID) in Infants (CARMA)

12. marts 2019 opdateret af: Assistance Publique - Hôpitaux de Paris

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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

830

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

1 år til 2 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: infants followed by pediatrician
1 blood sample of 9 ml. 3-day food diary , according to the European Food Safety Authority methodology

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum ferritin level
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Haemoglobin blood level
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 1
Day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. januar 2016

Primær færdiggørelse (Faktiske)

15. januar 2018

Studieafslutning (Faktiske)

1. maj 2018

Datoer for studieregistrering

Først indsendt

25. juni 2015

Først indsendt, der opfyldte QC-kriterier

25. juni 2015

Først opslået (Skøn)

29. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. marts 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. marts 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Blood samples

3
Abonner