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

Phase 1

Completed

• Conditions: Recurrent Neural Tube Defects
• Interventions: Drug: Folic Acid and inositol; Drug: Folic acid and placebo

• Registration Number: NCT00452829
• Lead Sponsor: Institute of Child Health

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 Timeline

• Study First Submitted: 2007-03-27
• Study First Submitted QC: 2007-03-27
• Study First Posted: 2007-03-28
• Study Start: 2009-09
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Folic Acid and inositol	5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD) and 1 g inositol,
Control Group	Folic acid and placebo	5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD)and 1 g placebo

Trial Locations

Locations (1)

Neural Development Unit, Institute of Child Health; 🇬🇧 London, United Kingdom