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Clinical Effects of a Nucleotides-Supplemented Infant Formula

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00292812
First Posted: February 16, 2006
Last Update Posted: October 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Materna Laboratories
Information provided by:
Soroka University Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00292812     History of Changes
Other Study ID Numbers: Sor4123ctil
First Submitted: February 15, 2006
First Posted: February 16, 2006
Last Update Posted: October 23, 2007
Last Verified: May 2007

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