New Infant Formula Supports Adequate Growth in Healthy Infants

Status Not yet recruiting

Clinical Trial Summary

The objective of the present study is to evaluate the growth, safety, and tolerance in healthy, term infants consuming a new to market infant formula (Formula A) and a commercially available infant formula (Formula B) with daily weight gain as the primary outcome. As secondary outcomes, the study will evaluate other growth parameters, tolerance, and safety.

Clinical Trial Description

This is a controlled randomized parallel assignment, masked (Participant, Care Provider, Investigator, Outcomes Assessor) study. Healthy infants will be assigned an Investigational (Formula A) experimental new milk based infant formula, or an active comparator Control (Formula B) Enfamil (trademark brand name) marketed milk based infant formula. The period for the study is 365 days (52 weeks) using repeated-measures mixed model (RMMM). Anthropometry, formula intake, tolerance, and stool characteristics will be assessed. Medically confirmed adverse events will be recorded throughout the study. ;

Study Design

Related Conditions & MeSH terms

Infant Development

Clinical Trial Details

NCT number	NCT03614468
Study type	Interventional
Source	Worthy Health
Contact	Fred Worthy
Phone	310 487-9971
Email	fred@worthy-health.com
Status	Not yet recruiting
Phase	N/A
Start date	May 8, 2019
Completion date	May 25, 2020

View Details

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