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

This study has suspended participant recruitment.
(insufficient recruitment)
Sponsor:
Information provided by:
Bledina
ClinicalTrials.gov Identifier:
NCT00554814
First received: November 6, 2007
Last updated: November 14, 2008
Last verified: November 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014