Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292812
Status:
COMPLETED
Last Update Posted:
2007-10-23
First Post:
2006-02-15
Brief Title:
Clinical Effects of a Nucleotides-Supplemented Infant Formula
Sponsor:
Soroka University Medical Center
Organization:
Soroka University Medical Center
Study Overview
Official Title:
The Clinical Effects of an Infant Formula Supplemented With Various Concentrations of Nucleotides
Status:
COMPLETED
Status Verified Date:
2007-05
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 study hypothesis is that different concentrations of nucleotides supplementation of an infant formula might affect differently growth andor other clinical parameters in neonates
Detailed Description:
Three groups of 50 newborn infants each will be fed for 30 days an infant formula supplemented with either 49 mg100 kcal or 106 mg100 kcal of nucleotides or with no supplementation Newborns will be monitored prospectively for the following outcome parameters
Growth percentiles
Behaviour and infantile colic
Bowel habits
Side effects
Growth percentiles
Behaviour and infantile colic
Bowel habits
Side effects
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