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

Sponsored by:	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:	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

Resource links provided by NLM:

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
3: Experimental Blédilait Biofer® milk (1,1mg/100kcal)	Drug: Blédilait Biofer® Blédilait Biofer® milk (1,1mg/100kcal)
1: Experimental Blédilait Biofer® milk (2mg/100kcal)	Drug: Bledilait Biofer® Bledilait Biofer® 2 mg/100 kcal
2: Active Comparator 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

Unaffiliated

More Information

No publications provided

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 History of Changes
Health Authority:	France: Direction Générale de la Santé

Keywords provided by Bledina:

Iron deficiency
Ferritin
Encapsulated iron
Infant formula

Study placed in the following topic categories:

Iron Supplement
Metabolic Diseases
Hematologic Diseases
Anemia

Iron Metabolism Disorders
Iron
Metabolic Disorder
Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Metabolic Diseases
Hematologic Diseases
Anemia

Anemia, Hypochromic
Iron Metabolism Disorders
Anemia, Iron-Deficiency

ClinicalTrials.gov processed this record on July 02, 2009