Safety Study of Infant Formula With Partially Hydrolized Whey - Full Text View

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:

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.
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
Infant Behaviour , Growth and Bowel Habits	Dietary Supplement: partially hydrolyzed whey Dietary Supplement: Nan HA

MedlinePlus related topics:

Dietary Supplements Infant and Toddler Nutrition

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

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

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 ]

Estimated Enrollment:	60
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Infants will be fed the new hydrolyzate formula.	Dietary Supplement: partially hydrolyzed whey Total infant feeding by study formula.
2: Placebo Comparator Nan HA infant formula	Dietary Supplement: partially hydrolyzed whey Total infant feeding by study formula. Dietary Supplement: Nan HA Toatl infant diet by study formula.

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

Contacts


Contact: Zvi Weizman, MD	972-8- 6400310	wzvi@bgu.ac.il

Contact: Galina Ling, MD	972-8- 6400310	ling@bgu.ac.il

Locations


Israel
	Soroka Medical Center	Not yet recruiting
	Beer-Sheva, Israel, 84101
	Contact: Zvi Weizman, MD 972-8- 6400310 wzvi@bgu.ac.il
	Principal Investigator: Zvi Weizman, MD

Sponsors and Collaborators

Soroka University Medical Center

Investigators


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

More Information

Responsible Party:	Materna Labs, Maabarot, Israel. ( Chaim Zegerman )
Study ID Numbers:	Sor461707ctil
First Received:	October 22, 2007
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00548106
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Soroka University Medical Center:

infant formula, milk allergy, hydrolized whey

Study placed in the following topic categories:

Hypersensitivity

Milk Hypersensitivity

Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00548106