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

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ClinicalTrials.gov Identifier: NCT00554814
Recruitment Status : Suspended (insufficient recruitment)
First Posted : November 7, 2007
Last Update Posted : November 17, 2008
Information provided by:

Study Description
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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2007
Estimated Primary Completion Date : November 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)

Outcome Measures

Primary Outcome Measures :
  1. Serum ferritin value measured after 2 months of studied milks consumption. [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. - 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554814

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

Responsible Party: Valérie BRENAS, Bledina
ClinicalTrials.gov Identifier: NCT00554814     History of Changes
Other Study ID Numbers: BL010
N° ID RCB : 2007-A00684-49
First Posted: November 7, 2007    Key Record Dates
Last Update Posted: November 17, 2008
Last Verified: November 2008

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