NCT00452829

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Institute of Child Health · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Recurrent Neural Tube Defects

Interventions

Type	Name	Description
DRUG	Folic Acid and inositol	Folic Acid and inositol
DRUG	Folic acid and placebo	Folic acid and placebo

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2007-03-28
• Last updated: 2015-06-24

Locations

1 site across 1 country: United Kingdom