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

This study is currently recruiting participants.

Verified by Institute of Child Health, March 2007

First Received: March 27, 2007 No Changes Posted

Sponsor:	Institute of Child Health
Information provided by:	Institute of Child Health
ClinicalTrials.gov Identifier:	NCT00452829

Purpose

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.

Condition	Intervention	Phase
Recurrent Neural Tube Defects	Drug: Folic Acid and inositol Drug: Folic acid and placebo	Phase I

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)

Resource links provided by NLM:

MedlinePlus related topics: Neural Tube Defects

Drug Information available for: Folic acid Inositol

U.S. FDA Resources

Further study details as provided by Institute of Child Health:

Estimated Enrollment:

100

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452829

Contacts

Contact: Mrs K Burren

0207 905 2326

ponti@ich.ucl.ac.uk

Locations

United Kingdom
Neural Development Unit, Institute of Child Health	Recruiting
London, United Kingdom, WC1N 1EH
Contact: Katie Burren 0207 905 2326
Principal Investigator: Andrew Copp, Prof

Sponsors and Collaborators

Institute of Child Health

Investigators

Principal Investigator:

Andrew Copp, Prof

Institute Of Child Health and Great Ormond Street Hospital

More Information

No publications provided

Study ID Numbers:	05ND07
Study First Received:	March 27, 2007
Last Updated:	March 27, 2007
ClinicalTrials.gov Identifier:	NCT00452829 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Neural Tube Defects
Vitamin B Complex
Nervous System Malformations
Hematinics
Growth Substances
Hematologic Agents
Nervous System Diseases
Inositol

Physiological Effects of Drugs
Pharmacologic Actions
Folic Acid
Therapeutic Uses
Vitamins
Micronutrients
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 27, 2009