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Formula With Modified Content of Protein and Improved Fatty Acids and Their Impact on Infant Growth and Health

NCT01094080 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 505

Last updated 2020-09-02

No results posted yet for this study

Summary

In this study, the suitability of an infant formula with a modified content of protein and fatty acid pattern (LC-PUFA) for healthy term infants will be investigated.

Primary hypothesis to be tested is: an infant formula with a modified protein content is non inferior compared to a standard infant formula in respect to the growth of healthy term infants.

Conditions

  • Infant Nutrition

Interventions

OTHER

standard infant formula

infants are fed a commercial formula

OTHER

modified infant formula

the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added

OTHER

breast milk

infants are breast fed

Sponsors & Collaborators

  • HiPP GmbH & Co. Vertrieb KG

    collaborator INDUSTRY

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Principal Investigators

  • Berthold Koletzko, Prof. · Hauner Children Hospital, Ludwig Maximilians Universität

  • Tatjana Nicolić Nicolić, Dr. · Institute for Gynecology and Obstretition of Clinical Center Belgrade

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-09-30
Completion
2018-05-31

Countries

  • 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 NCT01094080 on ClinicalTrials.gov