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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014