Clinical Effects of a Nucleotides-Supplemented Infant Formula
Not Applicable
Completed
- Conditions
- Nutritional Requirements
- Registration Number
- NCT00292812
- Lead Sponsor
- Soroka University Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Healthy newborns aged 0-30 days.
Exclusion Criteria
- Prematurity
- Chronic illness
- Failure to thrive
- Milk allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Growth percentiles, Behaviour and infantile colic, Bowel habits.
- Secondary Outcome Measures
Name Time Method Side effects.
Trial Locations
- Locations (1)
Soroka Medical Center
🇮🇱Beer-Sheva, Israel