Clinical Effects of a Nucleotides-Supplemented Infant Formula

October 22, 2007 updated by: Soroka University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-Sheva, Israel, 84101
        • Soroka Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy newborns aged 0-30 days.

Exclusion Criteria:

  • Prematurity
  • Chronic illness
  • Failure to thrive
  • Milk allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Growth percentiles, Behaviour and infantile colic, Bowel habits.

Secondary Outcome Measures

Outcome Measure
Side effects.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Collaborators

Materna Laboratories

Investigators

  • Principal Investigator: Zvi Weizman, MD, Head, Pediatric GI and Nutrition Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 15, 2006

First Submitted That Met QC Criteria

February 15, 2006

First Posted (Estimate)

February 16, 2006

Study Record Updates

Last Update Posted (Estimate)

October 23, 2007

Last Update Submitted That Met QC Criteria

October 22, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Sor4123ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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