Safety Study of Infant Formula With Partially Hydrolized Whey

Not Applicable

Withdrawn

• Conditions: Growth Failure
• Interventions: Dietary Supplement: partially hydrolyzed whey; Dietary Supplement: Nan HA

• Registration Number: NCT00548106
• Lead Sponsor: Soroka University Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2007-10-22
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Status Verified: 2010-07
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	partially hydrolyzed whey	Infants will be fed the new hydrolyzate formula.
2	partially hydrolyzed whey	Nan HA infant formula
2	Nan HA	Nan HA infant formula

Primary Outcome Measures

Name	Time	Method
Growth parameters, colic and bowel movements parameters.	3 months

Secondary Outcome Measures

Name	Time	Method
Side effects	3 months

Trial Locations

Locations (1)

Soroka Medical Center; 🇮🇱 Beer-Sheva, Israel