Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452829
Status:
COMPLETED
Last Update Posted:
2015-06-24
First Post:
2007-03-27
Brief Title:
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid PONTI Study
Sponsor:
Institute of Child Health
Organization:
Institute of Child Health
Study Overview
Official Title:
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid PONTI Study
Status:
COMPLETED
Status Verified Date:
2015-06
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 develop a randomised double blind clinical trial to compare i folic acid plus inositol with ii folic acid plus placebo for prevention of recurrent neural tube defects
Detailed Description:
Women were eligible to join the PONTI pilot study if they had a history of previous NTD-affected pregnancy were planning to become pregnant again and were prepared to be randomised to one of the two study arms Both study and control groups received 5 mg folic acid the standard UK supplement for pregnancies at high risk of NTD the study group additionally received 1 g inositol whereas the control group was prescribed a placebo instead of inositol
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