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

• Status: Suspended
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bledina
• Treatments: Iron

Criteria

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