Latent Iron Deficiency Clinical Trial
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
| Verified date | November 2008 |
| Source | Bledina |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Direction Générale de la Santé |
| Study type | Interventional |
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.
| Status | Suspended |
| Enrollment | 249 |
| Est. completion date | December 2008 |
| Est. primary completion date | November 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Months to 12 Months |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Alain BOCQUET | Besançon |
| Lead Sponsor | Collaborator |
|---|---|
| Bledina |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Serum ferritin value measured after 2 months of studied milks consumption. | 2 months | No | |
| Secondary | - Serum ferritin value - Serum ferritin evolution - CMV evolution - Red blood cells evolution - Common Infectious diseases - Antibiotic consumption | baseline, baseline + 2 months, baseline + 4 months | No |