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Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up

NCT01143233 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 503

Last updated 2017-11-30

No results posted yet for this study

Summary

The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants.

Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life.

4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.

Conditions

  • Disturbance of Growth

Interventions

OTHER

control formula

infants are fed a commercial hydrolyzed formula

OTHER

intervention formula 1

formula has hydrolysed protein and a different protein content

OTHER

intervention formula 2

formula has hydrolysed protein, different protein content and pro- and prebiotics

OTHER

intervention formula 3

formula has hydrolysed protein, different protein content and pro- and prebiotics

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • HiPP GmbH & Co. Vertrieb KG

    lead INDUSTRY

Principal Investigators

  • Ulrich Wahn, Prof. · Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie

  • Kirsten Beyer, Prof · Charité - Universitätsmedizin. Campus Virchow-Klinikum. Klinik für Pädiatrie mit Schwerpunkt Pneumologie/Immunologie

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
27 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-07-31
Completion
2017-08-31

Countries

  • Austria
  • Germany
  • Serbia

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 NCT01143233 on ClinicalTrials.gov