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

November 14, 2008 updated by: Bledina

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

249

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • Alain BOCQUET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum ferritin value measured after 2 months of studied milks consumption.
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
- 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
baseline, baseline + 2 months, baseline + 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bledina

Investigators

  • Principal Investigator: Jacques LANGUE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

November 1, 2008

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

November 6, 2007

First Submitted That Met QC Criteria

November 6, 2007

First Posted (Estimate)

November 7, 2007

Study Record Updates

Last Update Posted (Estimate)

November 17, 2008

Last Update Submitted That Met QC Criteria

November 14, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL010
  • N° ID RCB : 2007-A00684-49

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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