Nutritional Requirements Clinical Trial
Official title:
The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides
The study hypothesis is that different concentrations of nucleotides' supplementation of an infant formula might affect differently growth and/or other clinical parameters in neonates.
Three groups of 50 newborn infants each, will be fed for 30 days an infant formula
supplemented with either 4.9 mg/100 kcal or 10.6 mg/100 kcal of nucleotides or with no
supplementation. Newborns will be monitored prospectively for the following outcome
parameters:
- Growth percentiles.
- Behaviour and infantile colic.
- Bowel habits.
- Side effects.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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