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Sponsored by: |
Bledina |
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Information provided by: | Bledina |
ClinicalTrials.gov Identifier: | NCT00554814 |
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 |
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Latent Iron Deficiency |
Drug: Bledilait Biofer® Drug: Milk supplemented with ferrous sulphate Drug: Blédilait Biofer® |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
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 |
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 |
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3: Experimental
Blédilait Biofer® milk (1,1mg/100kcal)
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Drug: Blédilait Biofer®
Blédilait Biofer® milk (1,1mg/100kcal)
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1: Experimental
Blédilait Biofer® milk (2mg/100kcal)
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Drug: Bledilait Biofer®
Bledilait Biofer® 2 mg/100 kcal
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2: Active Comparator
Milk supplemented with ferrous sulphate (2mg/100kcal)
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Drug: Milk supplemented with ferrous sulphate
Milk supplemented with ferrous sulphate (2mg/100kcal)
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Ages Eligible for Study: | 6 Months to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Bledina ( Valérie BRENAS ) |
Study ID Numbers: | BL010, N° ID RCB : 2007-A00684-49 |
Study First Received: | November 6, 2007 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00554814 |
Health Authority: | France: Direction Générale de la Santé |
Iron deficiency Ferritin Encapsulated iron Infant formula |
Metabolic Diseases Hematologic Diseases Anemia Iron Metabolism Disorders |
Metabolic disorder Iron Anemia, Iron-Deficiency |
Anemia, Hypochromic |