Ignite Creation Date:
2024-05-06 @ 2:18 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02010749
Status:
COMPLETED
Last Update Posted:
2013-12-13
First Post:
2013-11-06
Brief Title:
Protein Concentration in Infant Formula A Follow-up Study of Growth at 2 Years of Age
Sponsor:
Société des Produits Nestlé SPN
Organization:
Société des Produits Nestlé SPN
Study Overview
Official Title:
Protein Concentration in Infant Formula A Follow-up Study of Growth at 2 Years of Age
Status:
COMPLETED
Status Verified Date:
2013-12
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 primary objective of the study was to compare the growth parameters of children approximately 2 years of age who as infants were randomized to receive either a lower-protein formula experimental formula EF with 128 gL protein or a standard formula SF with 141 gL protein or who were human milk HM fed for the first 4 months of life The secondary objective was to describe diet and nutrient intake in this cohort of children The exploratory objectives were to describe stool microbiota in a subset of this cohort and stool composition stool soap and nonsoap fatty acids total fatty acids and minerals in a second subset of this cohort
The mean age of subjects was 330 months due to a delay in the study start-up
The mean age of subjects was 330 months due to a delay in the study start-up
Detailed Description:
This was an observational single-site follow-up study of healthy children who as infants who had completed study 9052A1-3000 An attempt was made to contact all subjects who had completed study 9052A1-3000 by telephone to ask them to participate in study 9052A1-3001 Approximately 66 and 60 subjects were planned to participate in the stool microbiota and stool composition substudies respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None