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

Sponsor:	Bledina
Information provided by:	Bledina
ClinicalTrials.gov Identifier:	NCT00554814

Purpose

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:

MedlinePlus related topics: Iron

Drug Information available for: Ferrous sulfate

U.S. FDA Resources

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)

Eligibility

Ages Eligible for Study:	6 Months to 12 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00554814

Locations

France
Alain BOCQUET
Besançon, France, 25000

Sponsors and Collaborators

Bledina

Investigators

Principal Investigator:

Jacques LANGUE

More Information

No publications provided

Responsible Party:	Valérie BRENAS, Bledina
ClinicalTrials.gov 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
Ferritin
Encapsulated iron
Infant formula

Additional relevant MeSH terms:

Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012