NCT00292812
Completed
Not Applicable
The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nutritional Requirements
- Sponsor
- Soroka University Medical Center
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Growth percentiles, Behaviour and infantile colic, Bowel habits.
- Status
- Completed
- Last Updated
- 18 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy newborns aged 0-30 days.
Exclusion Criteria
- •Prematurity
- •Chronic illness
- •Failure to thrive
- •Milk allergy
Outcomes
Primary Outcomes
Growth percentiles, Behaviour and infantile colic, Bowel habits.
Secondary Outcomes
- Side effects.
Study Sites (1)
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