Safety Study of Infant Formula With Partially Hydrolized Whey

June 13, 2012 updated by: Soroka University Medical Center

Evaluation of a New Cow's Milk Infant Formula Containing Partially Hydrolized Whey

The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.

The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.

There will be two study groups, each receiving one of the following formulas:

  1. The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
  2. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study will be a randomized, double-blind, prospective trial. Newborn infants (enrollment age 0-14 days) will be assigned randomly to receive one of two products, provided in identical packages except for the lid color. Neither the investigators nor the parents will know which product the infant is receiving.

The infants will be monitored at study enrollment, and at 4, 8, and 12 weeks of age.

There will be two study groups, each receiving one of the following formulas:

  1. The new partially hydrolyzed whey formula (NF) - Materna cow's milk infant formula containing partially hydrolyzed whey protein, produced and packaged by Materna Laboratories, Maabarot.
  2. The currently marketed partially hydrolyzed whey formula (CF) - Nan HA, produced by Nestlé. In order to maintain blinding, the Nan HA will be repacked in packaging identical to the Materna product, except for the lid color

Study Type

Interventional

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 term neonates whose mothers are not able or choose not to breastfeed for medical, social, or personal reasons, will be recruited

Exclusion Criteria:

  • Twins
  • Premature or low birth weight (< 2500 g).
  • Chromosomal abnormalities or congenital malformations.
  • Jaundice of more than 12 mg% and/or phototherapy.
  • Treatment with antibiotics or other drugs during the last three days or more prior to the commencement of the study.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Infants will be fed the new hydrolyzate formula.
Dietary supplement: partially hydrolyzed whey
Total infant feeding by study formula.
Other Names:
  • Other names are not available yet.
Placebo Comparator: 2
Nan HA infant formula
Dietary supplement: partially hydrolyzed whey
Total infant feeding by study formula.
Other Names:
  • Other names are not available yet.
Dietary supplement: Nan HA
Total infant diet by study formula.
Other Names:
  • Not available yet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Growth parameters, colic and bowel movements parameters.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Soroka University Medical Center

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 Registration Dates

First Submitted

October 22, 2007

First Submitted That Met QC Criteria

October 22, 2007

First Posted (Estimate)

October 23, 2007

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sor461707ctil

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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