Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT01905605
Status:
WITHDRAWN
Last Update Posted:
2020-09-02
First Post:
2013-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phosphatidylcholine Supplementation in Infants
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating
Status:
WITHDRAWN
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding not secured. IRB approval has been withdrawn as of January 2017.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. Infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. This study will examine whether providing a nutritional supplement, phosphatidylcholine, for two months in infancy will result in an increased likelihood of developing more robust sensory gating.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: