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Safety Study of Infant Formula With Partially Hydrolized Whey

NCT00548106 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-06-14

No results posted yet for this study

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

Conditions

  • Growth Failure

Interventions

DIETARY_SUPPLEMENT

partially hydrolyzed whey

Total infant feeding by study formula.

DIETARY_SUPPLEMENT

Nan HA

Total infant diet by study formula.

Sponsors & Collaborators

  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • Zvi Weizman, MD · Head, Pediatric GI and Nutrition Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00548106 on ClinicalTrials.gov