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New Infant Formula Supports Adequate Growth in Healthy Infants

NCT03614468 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2019-02-26

No results posted yet for this study

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.

Conditions

  • Infant Development

Interventions

OTHER

Formula A

Formula A is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.

OTHER

Formula B

Formula B is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.

Sponsors & Collaborators

  • Worthy Health

    lead INDUSTRY

Principal Investigators

  • Fred Worthy · Chairman, Worthy Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2020-05-08
Completion
2020-05-25

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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 NCT03614468 on ClinicalTrials.gov