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Safety Study of Infant Formula With Partially Hydrolized Whey

This study has been withdrawn prior to enrollment.
(Study withdrawn due to the company decision)
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00548106
First received: October 22, 2007
Last updated: June 13, 2012
Last verified: July 2010
History of Changes
  Purpose

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

Condition Intervention
Growth Failure
 Dietary Supplement: partially hydrolyzed whey
Dietary Supplement: Nan HA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of a New Cow's Milk Infant Formula Containing Partially Hydrolized Whey

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Growth parameters, colic and bowel movements parameters. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Arms Assigned Interventions
Experimental: 1
Infants will be fed the new hydrolyzate formula.
 Dietary Supplement: partially hydrolyzed whey
Total infant feeding by study formula.
Other Name: 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 Name: Other names are not available yet.
Dietary Supplement: Nan HA
Total infant diet by study formula.
Other Name: Not available yet.

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
  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00548106

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

No publications provided

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00548106     History of Changes
Other Study ID Numbers: Sor461707ctil
Study First Received: October 22, 2007
Last Updated: June 13, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Soroka University Medical Center:
infant formula, milk allergy, hydrolized whey

Additional relevant MeSH terms:
Failure to Thrive
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013