Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04671576
Status:
COMPLETED
Last Update Posted:
2022-09-28
First Post:
2020-12-11
Brief Title:
Growth and Safety Clinical Trial on a New Infant Formula
Sponsor:
Nara Organics
Organization:
Nara Organics
Study Overview
Official Title:
Evaluation of Growth and Safety of Healthy Term Infants Consuming an Organic Formula
Status:
COMPLETED
Status Verified Date:
2022-08
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 the study is to assess age-appropriate growth of healthy infants fed a new organic milk-based infant formula
Detailed Description:
A 16-weeks length randomized controlled double-blind parallel study designed to evaluate growth and tolerance of healthy infants fed milk-based infant formula The study has been designed in accordance with Good Clinical Practice guidelines and the requirements of the Code of Federal Regulations 21 CFR 10696
Study Oversight
Has Oversight DMC:
None
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?:
None