NCT05508750

Growth and Safety Clinical Trial on a New Infant Formula

A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Jovie USA, LLC · Industry
• Sex: All
• Age: 0 Days – 14 Days
• Healthy volunteers: Accepted

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

Type	Name	Description
OTHER	New Infant Formula	New infant formula fed daily ad libitum
OTHER	Commercial Infant Formula	Commercially available infant formula fed daily ad libitum

Timeline

• Start date: 2022-09-21
• Primary completion: 2024-01-02
• Completion: 2024-01-02
• First posted: 2022-08-19
• Last updated: 2024-01-17

Locations

1 site across 1 country: United States