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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Bowel Movement Dietary Supplements Diets Infant and Toddler Nutrition

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 ]

Estimated Enrollment:	60
Study Start Date:	January 2010
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	January 2011 (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 Total 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
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:	Materna Labs, Maabarot, Israel. ( Chaim Zegerman )
Study ID Numbers:	Sor461707ctil
Study First Received:	October 22, 2007
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00548106 History of Changes
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

ClinicalTrials.gov processed this record on September 10, 2009