MedTrace Logo

Growth and Safety Clinical Trial on a New Infant Formula

NCT05508750 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2024-01-17

No results posted yet for this study

Summary

The aim of this study is to assess age-appropriate growth of healthy infants fed a new infant formula. In this randomized, controlled trial, healthy, term, formula-fed infants will be randomized to one of two infant formulas: a standard, commercially-available infant formula for term infants or the new infant formula for term infants for 16 weeks. A reference group of human milk-fed infants will also be enrolled. This study is designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations, 21CFR106.96. This study allows caregivers to participate completely from the comfort of their own home.

Conditions

  • Weight Gain

Interventions

OTHER

New Infant Formula

New infant formula fed daily ad libitum

OTHER

Commercial Infant Formula

Commercially available infant formula fed daily ad libitum

Sponsors & Collaborators

  • IQVIA RDS Inc.

    collaborator INDUSTRY

  • ObvioHealth

    collaborator INDUSTRY

  • Jovie USA, LLC

    lead INDUSTRY

Principal Investigators

  • Parth Shah, MD FAPCR · ObvioHealth

  • Dawn Ross, Director Clinical Project Management · IQVIA RDS Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-21
Primary Completion
2024-01-02
Completion
2024-01-02

Countries

  • United States

Study Locations

More Related Trials

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 NCT05508750 on ClinicalTrials.gov