Iron Deficiency in Young Children Living in FranceCARMANCT02484274
Iron Deficiency (ID) in Infants
A study testing Blood samples in people with Iron Deficiency in Young Children Living in France, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 26 months
- Conditions the study is for
- Iron Deficiency in Young Children Living in France
- What is being tested?
- Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jan 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 26 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Blood samples
- Keywords
- iron-deficiency, iron-deficiency anemia, infants and toddlers, industrialised countries, population-based study, prevalence and risk factors, screening strategies, diagnosis markers, primary prevention
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesBiological
1 blood sample of 9 ml. 3-day food diary , according to the European Food Safety Authority methodology
| Study group | Role | What they receive |
|---|---|---|
| infants followed by pediatrician | Other | Not described Receives: Biological: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin level
Iron deficiency determined by serum ferritin level < 10 µg/l with C Reactive Protein (CRP) < 5 mg/l
Measured: Between day 8 and day 15 (or plus 15 days)
Secondary outcomes (4)
Haemoglobin blood level
Iron-deficiency anemia determined by haemoglobin blood level < 11g/dl in infant with iron deficiency
Measured: Between day 8 and day 15 (or plus 15 days)
Dosage of biochemical markers (hepcidin, erythrocytic protoporphyrin)
Measured: Between day 8 and day 15 (or plus 15 days)
Iron intake related to toddler milk formula
Food diary
Measured: Between day 2 and day 7 (or plus 15 days)
Parents' economical and educational level
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start6 Jan 2016
- Primary completion15 Jan 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency in Young Children Living in FranceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- 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, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Martin Chalumeau, MD, PhD, Study director, INSERM UMR1153
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484274
- Sponsor's protocol ID
- P140314
- Acronym
- CARMA
- Status last verified
- Mar 2026
- First submitted
- 25 Jun 2015
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20923825Domellof 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.
PubMed 24135983Ghisolfi 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.
PubMed 23098567Sacri 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.
PubMed 32507584Sacri 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.
PubMed 29228047Guivarch 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.
PubMed 33836187
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency in Infants : Population-wide Study of the Protective Role of Toddler Milk Formula
- ClinicalTrials.gov ID
- NCT02484274
- Acronym / sponsor ID
- CARMA / P140314
- Keywords
- iron-deficiency, iron-deficiency anemia, infants and toddlers, industrialised countries, population-based study, prevalence and risk factors, screening strategies, diagnosis markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- 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, URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Jan 2016 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infants followed by pediatrician | Other | Biological: Blood samples |
Who may qualify
- Ages
- 22 to 26 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples1 blood sample of 9 ml. 3-day food diary , according to the European Food Safety Authority methodology | Biological | infants followed by pediatrician |
Primary outcome
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
4 secondary outcomes
Haemoglobin blood level
Time frame: Between day 8 and day 15 (or plus 15 days)
Dosage of biochemical markers (hepcidin, erythrocytic protoporphyrin)
Time frame: Between day 8 and day 15 (or plus 15 days)
Iron intake related to toddler milk formula
Time frame: Between day 2 and day 7 (or plus 15 days)
Parents' economical and educational level
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Background: PubMed 20923825Baker 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.
- Background: PubMed 24135983Domellof 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.
- Background: PubMed 23098567Ghisolfi 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 publication: PubMed 32507584Sacri 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 publication: PubMed 29228047Sacri 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.
- Derived from this study: PubMed 33836187Guivarch 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Chalumeau, MD, PhD study director
INSERM UMR1153
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples in people with Iron Deficiency in Young Children Living in France, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum ferritin level (time frame: Between day 8 and day 15 (or plus 15 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484274, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.