| November 6, 2007 |
| November 14, 2008 |
| November 2007 |
| November 2008 (final data collection date for primary outcome measure) |
| Serum ferritin value measured after 2 months of studied milks consumption. [ Time Frame: 2 months ] [ Designated as safety issue: No ] |
| Serum ferritin value measured after 2 months of studied milks consumption. [ Time Frame: 2 months ] |
| Complete list of historical versions of study NCT00554814 on ClinicalTrials.gov Archive Site |
| - 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 ] |
| - 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 ] |
| |
| Interest of Biofer ® Compound Used in Blédilait Follow on Milk in Infant With Latent Iron Deficiency |
| 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. |
| |
| |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Latent Iron Deficiency |
- Drug: Bledilait Biofer®
- Drug: Milk supplemented with ferrous sulphate
- Drug: Blédilait Biofer®
|
- Experimental: Blédilait Biofer® milk (1,1mg/100kcal)
- Experimental: Blédilait Biofer® milk (2mg/100kcal)
- Active Comparator: Milk supplemented with ferrous sulphate (2mg/100kcal)
|
| |
| |
| Suspended |
| 249 |
| December 2008 |
| November 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 6 Months to 12 Months |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| France |
| |
| NCT00554814 |
| Valérie BRENAS, Bledina |
| BL010, N° ID RCB : 2007-A00684-49 |
| Bledina |
|
| Principal Investigator: |
Jacques LANGUE |
Unaffiliated |
|
|
| Bledina |
| November 2008 |
