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

B

Bledina

Status

Suspended

Conditions

Latent Iron Deficiency

Treatments

Drug: Bledilait Biofer®
Drug: Blédilait Biofer®
Drug: Milk supplemented with ferrous sulphate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00554814
BL010
N° ID RCB : 2007-A00684-49

Details and patient eligibility

About

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.

Enrollment

249 estimated patients

Sex

All

Ages

6 to 12 months old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

249 participants in 3 patient groups

3
Experimental group
Description:
Blédilait Biofer® milk (1,1mg/100kcal)
Treatment:
Drug: Blédilait Biofer®
1
Experimental group
Description:
Blédilait Biofer® milk (2mg/100kcal)
Treatment:
Drug: Bledilait Biofer®
2
Active Comparator group
Description:
Milk supplemented with ferrous sulphate (2mg/100kcal)
Treatment:
Drug: Milk supplemented with ferrous sulphate

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems