Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-03-09 @ 1:13 PM
Study NCT ID:
NCT05508750
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2022-08-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Growth and Safety Clinical Trial on a New Infant Formula
Sponsor:
Jovie USA, LLC
Organization:
Study Overview
Official Title:
A Randomized, Controlled Trial Evaluating Growth and Safety in Infants Fed a New Infant Formula
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: