Interest of Biofer ® Compound Used in Blédilait Follow on Milk in Infant With Latent Iron Deficiency

Study Overview
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Brief Summary
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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.

Official Title
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Interest of Biofer ® Compound Used in Blédilait Follow on Milk and Growing Milk on Iron Status Evolution in Infant With Latent Iron Deficiency

Conditions
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Latent Iron Deficiency

Intervention / Treatment
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* Drug: Bledilait Biofer®
* Drug: Milk supplemented with ferrous sulphate
* Drug: Blédilait Biofer®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3<br>Blédilait Biofer® milk (1,1mg/100kcal) | Drug: Blédilait Biofer®<br>* Blédilait Biofer® milk (1,1mg/100kcal)<br>|
| Experimental: 1<br>Blédilait Biofer® milk (2mg/100kcal) | Drug: Bledilait Biofer®<br>* Bledilait Biofer® 2 mg/100 kcal<br>|
| Active Comparator: 2<br>Milk supplemented with ferrous sulphate (2mg/100kcal) | Drug: Milk supplemented with ferrous sulphate<br>* Milk supplemented with ferrous sulphate (2mg/100kcal)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum ferritin value measured after 2 months of studied milks consumption. |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iron deficiency, Ferritin, Encapsulated iron, Infant formula