Iron Deficiency (ID) in Infants (CARMA)
Primary Purpose
Iron Deficiency in Young Children Living in France
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional prevention trial for Iron Deficiency in Young Children Living in France focused on measuring iron-deficiency, iron-deficiency anemia, infants and toddlers, industrialised countries, population-based study, prevalence and risk factors, screening strategies, diagnosis markers, primary prevention
Eligibility 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
Sites / Locations
- Necker-Enfants Malades hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
infants followed by pediatrician
Arm Description
Outcomes
Primary Outcome Measures
Serum ferritin level
Iron deficiency determined by serum ferritin level < 10 µg/l with C Reactive Protein (CRP) < 5 mg/l
Secondary Outcome Measures
Haemoglobin blood level
Iron-deficiency anemia determined by haemoglobin blood level < 11g/dl in infant with iron deficiency
Dosage of biochemical markers (hepcidin, erythrocytic protoporphyrin)
Iron intake related to toddler milk formula
Food diary
Parents' economical and educational level
Full Information
NCT ID
NCT02484274
First Posted
June 25, 2015
Last Updated
March 12, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
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
1. Study Identification
Unique Protocol Identification Number
NCT02484274
Brief Title
Iron Deficiency (ID) in Infants
Acronym
CARMA
Official Title
Iron Deficiency in Infants : Population-wide Study of the Protective Role of Toddler Milk Formula
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 6, 2016 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency in Young Children Living in France
Keywords
iron-deficiency, iron-deficiency anemia, infants and toddlers, industrialised countries, population-based study, prevalence and risk factors, screening strategies, diagnosis markers, primary prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
830 (Actual)
8. Arms, Groups, and Interventions
Arm Title
infants followed by pediatrician
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Blood samples
Intervention Description
1 blood sample of 9 ml. 3-day food diary , according to the European Food Safety Authority methodology
Primary Outcome Measure Information:
Title
Serum ferritin level
Description
Iron deficiency determined by serum ferritin level < 10 µg/l with C Reactive Protein (CRP) < 5 mg/l
Time Frame
Between day 8 and day 15 (or plus 15 days)
Secondary Outcome Measure Information:
Title
Haemoglobin blood level
Description
Iron-deficiency anemia determined by haemoglobin blood level < 11g/dl in infant with iron deficiency
Time Frame
Between day 8 and day 15 (or plus 15 days)
Title
Dosage of biochemical markers (hepcidin, erythrocytic protoporphyrin)
Time Frame
Between day 8 and day 15 (or plus 15 days)
Title
Iron intake related to toddler milk formula
Description
Food diary
Time Frame
Between day 2 and day 7 (or plus 15 days)
Title
Parents' economical and educational level
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Months
Maximum Age & Unit of Time
26 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Chalumeau, MD, PhD
Organizational Affiliation
INSERM UMR 1153
Official's Role
Study Director
Facility Information:
Facility Name
Necker-Enfants Malades hospital
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20923825
Citation
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.
Results Reference
background
PubMed Identifier
24135983
Citation
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.
Results Reference
background
PubMed Identifier
23098567
Citation
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.
Results Reference
background
PubMed Identifier
33836187
Citation
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.
Results Reference
derived
PubMed Identifier
32507584
Citation
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.
Results Reference
derived
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Iron Deficiency (ID) in Infants
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