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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00452829
Recruitment Status : Completed
First Posted : March 28, 2007
Last Update Posted : June 24, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Recurrent Neural Tube Defects Drug: Folic Acid and inositol Drug: Folic acid and placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)
Study Start Date : September 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: Study Group
5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD) and 1 g inositol,
Drug: Folic Acid and inositol
Folic Acid and inositol
Other Name: Study Group

Placebo Comparator: Control Group
5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD)and 1 g placebo
Drug: Folic acid and placebo
Folic acid and placebo
Other Name: Control Group

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

1. Women with a history of one or more NTD pregnancies (spina bifida, anencephaly or encephalocele) who wished to embark upon a further pregnancy.

Exclusion criteria

  1. Women who were unable to give informed consent for any reason (language difficulties, low IQ).

    Funding was not available to translate the information leaflets or to employ interpreters for the telephone interviews. It was intended to take appropriate measures to include these groups in a definitive follow-up trial.

  2. Maternal age outside 18 - 40 years of age. An upper limit of forty years was stipulated because there is increased risk of a pregnancy being affected by chromosomal abnormality which may result in a NTD, but which may not be similarly susceptible to prevention by nutrient supplementation.
  3. Cases where the previous affected child had abnormalities other than NTD, which might be suggestive of another underlying genetic aetiology, a chromosomal abnormality or fetal valproate syndrome. In these cases the underlying pathology would be different from spontaneous, isolated NTDs, and folic acid or inositol would not be expected to influence recurrence risk.
  4. Women who were epileptic and/or taking anti-epileptic medications including valproate. It was recognised that some anti-epileptic drugs increase the predisposition to NTDs and, such NTDs might be unresponsive to inositol supplementation.
  5. Women who did not have a GP or obstetrician in the UK. We needed to be able to monitor the pregnancy, confirm there were no contraindications to inositol supplementation, and seek outcome data. We did not have the facilities to seek this information for cases outside the UK.
  6. Women would be required to stop participation in the trial if the following criteria were met whilst taking the prescribed drugs;

    • Diagnosed with epilepsy and were therefore required to take anti-epileptics.
    • Failed to conceive within one year of starting the trial.
    • They no longer wished to conceive .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00452829

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United Kingdom
Neural Development Unit, Institute of Child Health
London, United Kingdom, WC1N 1EH
Sponsors and Collaborators
Institute of Child Health
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Principal Investigator: Andrew Copp, Prof Institute Of Child Health and Great Ormond Street Hospital
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Responsible Party: Institute of Child Health Identifier: NCT00452829    
Other Study ID Numbers: 05ND07
First Posted: March 28, 2007    Key Record Dates
Last Update Posted: June 24, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Neural Tube Defects
Spinal Dysraphism
Nervous System Malformations
Nervous System Diseases
Congenital Abnormalities
Folic Acid
Vitamin B Complex
Physiological Effects of Drugs