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Clinical Trials/NCT00292812
NCT00292812
Completed
Not Applicable

The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides

Soroka University Medical Center1 site in 1 country150 target enrollmentMarch 2006

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.

Registry
clinicaltrials.gov
Start Date
March 2006
End Date
October 2007
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

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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