Clinical Trial: Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Summary: 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.
Sponsor: Institute of Child Health
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Institute of Child Health
Dates:
Date Received: March 27, 2007
Date Started: September 2009
Date Completion:
Last Updated: June 23, 2015
Last Verified: June 2015