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

This study has suspended participant recruitment.
(insufficient recruitment)
Information provided by:
Bledina Identifier:
First received: November 6, 2007
Last updated: November 14, 2008
Last verified: November 2008

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.

Condition Intervention
Latent Iron Deficiency
Drug: Bledilait Biofer®
Drug: Milk supplemented with ferrous sulphate
Drug: Blédilait Biofer®

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Interest of Biofer ® Compound Used in Blédilait Follow on Milk and Growing Milk on Iron Status Evolution in Infant With Latent Iron Deficiency

Resource links provided by NLM:

Further study details as provided by Bledina:

Primary Outcome Measures:
  • Serum ferritin value measured after 2 months of studied milks consumption. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption [ Time Frame: baseline, baseline + 2 months, baseline + 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 249
Study Start Date: November 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3
Blédilait Biofer® milk (1,1mg/100kcal)
Drug: Blédilait Biofer®
Blédilait Biofer® milk (1,1mg/100kcal)
Experimental: 1
Blédilait Biofer® milk (2mg/100kcal)
Drug: Bledilait Biofer®
Bledilait Biofer® 2 mg/100 kcal
Active Comparator: 2
Milk supplemented with ferrous sulphate (2mg/100kcal)
Drug: Milk supplemented with ferrous sulphate
Milk supplemented with ferrous sulphate (2mg/100kcal)


Ages Eligible for Study:   6 Months to 12 Months
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Please refer to this study by its identifier: NCT00554814

Besançon, France, 25000
Sponsors and Collaborators
Principal Investigator: Jacques LANGUE
  More Information

No publications provided

Responsible Party: Valérie BRENAS, Bledina Identifier: NCT00554814     History of Changes
Other Study ID Numbers: BL010, N° ID RCB : 2007-A00684-49
Study First Received: November 6, 2007
Last Updated: November 14, 2008
Health Authority: France: Direction Générale de la Santé

Keywords provided by Bledina:
Iron deficiency
Encapsulated iron
Infant formula

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 15, 2014