Latent Iron Deficiency
Conditions
Keywords
Iron deficiency, Ferritin, Encapsulated iron, Infant formula
Brief summary
The primary purpose of the study is to demonstrate the superiority of Bledilait milk (Biofer® 2mg/100kcal) in comparison with ferrous sulphate supplemented milk (2 mg/100 kcal) in infants (6 to 12 months) with latent iron deficiency by measuring serum ferritin value after 2 months of consumption of studied milks.
Interventions
DRUGBledilait Biofer®
Bledilait Biofer® 2 mg/100 kcal
DRUGMilk supplemented with ferrous sulphate
Milk supplemented with ferrous sulphate (2mg/100kcal)
DRUGBlédilait Biofer®
Blédilait Biofer® milk (1,1mg/100kcal)
Sponsors
Bledina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
No
Inclusion criteria
* infant between 6 and 12 months of age, * preterm infant, low birth weight infant (\< 2,5 kg), multiple pregnancy, infant from mother with close pregnancies (2 babies in 2 years), * infant with a serum ferritin value \< 12ng/ml and with a normal haemoglobin value (\> 11 g/dl), i.e. with a latent iron deficiency, * infant whose parents or legal tutors have given written informed consent, * parents or legal tutors agreeing for 4 month follow-up by the investigator, * infant for which a clinical exam has been performed, * infant with health insurance.
Exclusion criteria
* infant with serum ferritin value \< 12 ng/ml and haemoglobin value \< 11 g/dl * infant already receiving medicinal iron supplementation, * infant with acquired or congenital defect, * infant presenting a significant metabolic, organic or digestive disease able to interfere with study (including hemochromatosis) * infant with congenital and/or chromosomal malformation * infant receiving a drug susceptible, according to the investigator, to interfere with the measured study parameters * infant needing specific infant formula (hypoallergenic, without cow milk proteins) * infant in a situation that could, according to investigator, interfere with an optimal participation to the study or be a health risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum ferritin value measured after 2 months of studied milks consumption. | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| - Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption | baseline, baseline + 2 months, baseline + 4 months |
Countries
France
Outcome results
None listed