Clinical Effects of a Nucleotides-Supplemented Infant Formula

This study has been completed.
Sponsor:
Collaborator:
Materna Laboratories
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00292812
First received: February 15, 2006
Last updated: October 22, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention
Nutritional Requirements
Drug: Nutritional supplementation (nucleotides)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Growth percentiles, Behaviour and infantile colic, Bowel habits.

Secondary Outcome Measures:
  • Side effects.

Estimated Enrollment: 150
Study Start Date: March 2006
Study Completion Date: October 2007
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.
  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy newborns aged 0-30 days.

Exclusion Criteria:

  • Prematurity
  • Chronic illness
  • Failure to thrive
  • Milk allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292812

Locations
Israel
Soroka Medical Center
Beer-Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Materna Laboratories
Investigators
Principal Investigator: Zvi Weizman, MD Head, Pediatric GI and Nutrition Unit
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00292812     History of Changes
Other Study ID Numbers: Sor4123ctil
Study First Received: February 15, 2006
Last Updated: October 22, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Soroka University Medical Center:
Infant nutrition
Nucleotides
Infant formula

ClinicalTrials.gov processed this record on April 15, 2014