NCT00292812CompletedNot Applicable
The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides
Soroka University Medical Center1 site in 1 country150 target enrollmentStarted: March 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Growth percentiles, Behaviour and infantile colic, Bowel habits.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Ages
- 1 Day to 30 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Investigators
Study Sites (1)
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