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

Bledina

Status: Suspended

Conditions: Latent Iron Deficiency

Treatments: Drug: Bledilait Biofer®; Drug: Blédilait Biofer®; Drug: Milk supplemented with ferrous sulphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00554814

BL010

N° ID RCB : 2007-A00684-49

Details and patient eligibility

About

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.

Enrollment: 249 estimated patients

Sex: All

Ages: 6 to 12 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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249 participants in 3 patient groups

3

Experimental group

Description:

Blédilait Biofer® milk (1,1mg/100kcal)

Treatment:

Drug: Blédilait Biofer®

1

Experimental group

Description:

Blédilait Biofer® milk (2mg/100kcal)

Treatment:

Drug: Bledilait Biofer®

2

Active Comparator group

Description:

Milk supplemented with ferrous sulphate (2mg/100kcal)

Treatment:

Drug: Milk supplemented with ferrous sulphate