Back to resultsPrevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)
Primary Purpose
Recurrent Neural Tube Defects
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Folic Acid and inositol
Folic acid and placebo
Sponsored by
About this trial
This is an interventional prevention trial for Recurrent Neural Tube Defects
Eligibility Criteria
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
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.
- 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.
- 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.
- 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.
- 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.
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 .
Sites / Locations
- Neural Development Unit, Institute of Child Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Study Group
Control Group
Arm Description
5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD) and 1 g inositol,
5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD)and 1 g placebo
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00452829
First Posted
March 27, 2007
Last Updated
June 23, 2015
Sponsor
Institute of Child Health
1. Study Identification
Unique Protocol Identification Number
NCT00452829
Brief Title
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)
Official Title
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Child Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Neural Tube Defects
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Group
Arm Type
Experimental
Arm Description
5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD) and 1 g inositol,
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD)and 1 g placebo
Intervention Type
Drug
Intervention Name(s)
Folic Acid and inositol
Other Intervention Name(s)
Study Group
Intervention Description
Folic Acid and inositol
Intervention Type
Drug
Intervention Name(s)
Folic acid and placebo
Other Intervention Name(s)
Control Group
Intervention Description
Folic acid and placebo
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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.
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.
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.
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.
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.
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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Copp, Prof
Organizational Affiliation
Institute Of Child Health and Great Ormond Street Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neural Development Unit, Institute of Child Health
City
London
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)
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