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Protein Concentration in Infant Formula: A Follow-up Study of Growth at 2 Years of Age

NCT02010749 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 267

Last updated 2013-12-13

No results posted yet for this study

Summary

The primary objective of the study was to compare the growth parameters of children approximately 2\* years of age, who as infants were randomized to receive either a lower-protein formula ("experimental formula"; EF) with 12.8 g/L protein or a standard formula (SF) with 14.1 g/L protein or who were human milk (HM) fed for the first 4 months of life. The secondary objective was to describe diet and nutrient intake in this cohort of children. The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition (stool soap and nonsoap fatty acids, total fatty acids, and minerals) in a second subset of this cohort.

(\* The mean age of subjects was 33.0 months due to a delay in the study start-up.)

Conditions

  • Bottle Feeding

Sponsors & Collaborators

  • Société des Produits Nestlé (SPN)

    lead INDUSTRY

Eligibility

Min Age
2 Years
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Philippines

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 NCT02010749 on ClinicalTrials.gov