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

Not Applicable

Suspended

• Conditions: Latent Iron Deficiency
• Interventions: Drug: Blédilait Biofer®; Drug: Milk supplemented with ferrous sulphate; Drug: Bledilait Biofer®

• Registration Number: NCT00554814
• Lead Sponsor: Bledina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-06
• Study First Submitted QC: 2007-11-06
• Study First Posted: 2007-11-07
• Status Verified: 2008-11
• Primary Completion: 2008-11
• Last Update Submitted: 2008-11-14
• Last Update Posted: 2008-11-17
• Study Completion: 2008-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 249

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Blédilait Biofer®	Blédilait Biofer® milk (1,1mg/100kcal)
2	Milk supplemented with ferrous sulphate	Milk supplemented with ferrous sulphate (2mg/100kcal)
1	Bledilait Biofer®	Blédilait Biofer® milk (2mg/100kcal)

Primary Outcome Measures

Name	Time	Method
Serum ferritin value measured after 2 months of studied milks consumption.	2 months

Secondary Outcome Measures

Name	Time	Method
- Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption	baseline, baseline + 2 months, baseline + 4 months

Trial Locations

Locations (1)

Alain BOCQUET; 🇫🇷 Besançon, France