Status:
COMPLETED
Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)
Lead Sponsor:
Institute of Child Health
Conditions:
Recurrent Neural Tube Defects
Eligibility:
FEMALE
18-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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 .
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00452829
Start Date
September 1 2009
End Date
June 1 2013
Last Update
June 24 2015
Active Locations (1)
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1
Neural Development Unit, Institute of Child Health
London, United Kingdom, WC1N 1EH