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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00554814 |
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Date of registration:
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06/11/2007 |
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Primary sponsor: |
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Public title:
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Interest of Biofer ® Compound Used in Blédilait Follow on Milk in Infant With Latent Iron Deficiency
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Scientific title:
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Interest of Biofer ® Compound Used in Blédilait Follow on Milk and Growing Milk on Iron Status Evolution in Infant With Latent Iron Deficiency |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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249 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT00554814 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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France
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Contacts
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Name:
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Jacques LANGUE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Months
Age maximum:
12 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Latent Iron Deficiency
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Intervention(s)
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Drug: Bledilait Biofer®
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Drug: Blédilait Biofer®
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Drug: Milk supplemented with ferrous sulphate
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Primary Outcome(s)
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Serum ferritin value measured after 2 months of studied milks consumption.
[Time Frame: 2 months]
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Secondary Outcome(s)
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- 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]
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Secondary ID(s)
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BL010
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N° ID RCB : 2007-A00684-49
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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