Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study) - Tabular View

Tracking Information

First Received Date ^ICMJE

March 27, 2007

Last Updated Date

March 27, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)

Official Title ^ICMJE

Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Recurrent Neural Tube Defects

Intervention ^ICMJE

Drug: Folic Acid and inositol
Drug: Folic acid and placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Women with a history of one or more isolated neural tube defects (spina bfida, anencephaly or encepalcele) who wish to embark ipon a further pregnancy

Gender

Female

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Mrs K Burren

0207 905 2326

ponti@ich.ucl.ac.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00452829

Responsible Party

Study ID Numbers ^ICMJE

05ND07

Study Sponsor ^ICMJE

Institute of Child Health

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Andrew Copp, Prof

Institute Of Child Health and Great Ormond Street Hospital

Information Provided By

Institute of Child Health

Verification Date

March 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP