Iron Deficiency in Young Children Living in France Clinical Trial
— CARMAOfficial title:
Iron Deficiency in Infants : Population-wide Study of the Protective Role of Toddler Milk Formula
| NCT number | NCT02484274 |
| Other study ID # | P140314 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 6, 2016 |
| Est. completion date | May 2018 |
| Verified date | February 2019 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 830 |
| Est. completion date | May 2018 |
| Est. primary completion date | January 15, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 22 Months to 26 Months |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Necker-Enfants Malades hospital | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Association Française de Pédiatrie Ambulatoire- AFPA, CERBA, Clinical and Therapeutic Association of Val de Marne: ACTIV, INSERM 1153, Centre de Recherche Epidémiologique et Biostatistique, Laboratoire de Biochimie, CHU Louis Mourier |
France,
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. — View Citation
Domellöf 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. Review. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum ferritin level | 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) | |
| Secondary | Haemoglobin blood level | 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) | |
| Secondary | Dosage of biochemical markers (hepcidin, erythrocytic protoporphyrin) | Between day 8 and day 15 (or plus 15 days) | ||
| Secondary | Iron intake related to toddler milk formula | Food diary | Between day 2 and day 7 (or plus 15 days) | |
| Secondary | Parents' economical and educational level | Day 1 |