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Iron Deficiency (ID) in Infants (CARMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02484274
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment Phase
Iron Deficiency in Young Children Living in France Biological: Blood samples Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 830 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Iron Deficiency in Infants : Population-wide Study of the Protective Role of Toddler Milk Formula
Actual Study Start Date : January 6, 2016
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Serum ferritin level [ Time Frame: 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


Secondary Outcome Measures :
  1. Haemoglobin blood level [ Time Frame: 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

  2. Dosage of biochemical markers (hepcidin, erythrocytic protoporphyrin) [ Time Frame: Between day 8 and day 15 (or plus 15 days) ]
  3. Iron intake related to toddler milk formula [ Time Frame: Between day 2 and day 7 (or plus 15 days) ]
    Food diary

  4. Parents' economical and educational level [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   22 Months to 26 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484274


Locations
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France
Necker-Enfants Malades hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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
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Study Director: Martin Chalumeau, MD, PhD INSERM UMR 1153
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02484274    
Other Study ID Numbers: P140314
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
iron-deficiency
iron-deficiency anemia
infants and toddlers
industrialised countries
population-based study
prevalence and risk factors
screening strategies
diagnosis markers
primary prevention
Additional relevant MeSH terms:
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Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases