Back to results

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

Primary Purpose

Latent Iron Deficiency

Status

Suspended

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Bledilait Biofer®

Milk supplemented with ferrous sulphate

Blédilait Biofer®

About this trial

This is an interventional prevention trial for Latent Iron Deficiency focused on measuring Iron deficiency, Ferritin, Encapsulated iron, Infant formula

Eligibility Criteria

6 Months - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Alain BOCQUET

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Blédilait Biofer® milk (1,1mg/100kcal)

Blédilait Biofer® milk (2mg/100kcal)

Milk supplemented with ferrous sulphate (2mg/100kcal)

Outcomes

Primary Outcome Measures

Serum ferritin value measured after 2 months of studied milks consumption.

Secondary Outcome Measures

- Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption

Full Information

NCT ID

NCT00554814

First Posted

November 6, 2007

Last Updated

November 14, 2008

Sponsor

Bledina

1. Study Identification

Unique Protocol Identification Number

NCT00554814

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Suspended

Why Stopped

insufficient recruitment

Study Start Date

November 2007 (undefined)

Primary Completion Date

November 2008 (Anticipated)

Study Completion Date

December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Bledina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Latent Iron Deficiency

Keywords

Iron deficiency, Ferritin, Encapsulated iron, Infant formula

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

249 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Blédilait Biofer® milk (1,1mg/100kcal)

Arm Title

Arm Type

Experimental

Arm Description

Blédilait Biofer® milk (2mg/100kcal)

Arm Title

Arm Type

Active Comparator

Arm Description

Milk supplemented with ferrous sulphate (2mg/100kcal)

Intervention Type

Drug

Intervention Name(s)

Bledilait Biofer®

Intervention Description

Bledilait Biofer® 2 mg/100 kcal

Intervention Type

Drug

Intervention Name(s)

Milk supplemented with ferrous sulphate

Intervention Description

Milk supplemented with ferrous sulphate (2mg/100kcal)

Intervention Type

Drug

Intervention Name(s)

Blédilait Biofer®

Intervention Description

Blédilait Biofer® milk (1,1mg/100kcal)

Primary Outcome Measure Information:

Title

Serum ferritin value measured after 2 months of studied milks consumption.

Time Frame

2 months

Secondary Outcome Measure Information:

Title

- 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacques LANGUE

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alain BOCQUET

City

Besançon

ZIP/Postal Code

25000

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs