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

NCT ID: NCT00452829

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-06-30

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.

Conditions

Recurrent Neural Tube Defects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Study Group

5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD) and 1 g inositol,

Group Type: EXPERIMENTAL

Folic Acid and inositol

Intervention Type: DRUG

Folic Acid and inositol

Control Group

5 mg folic acid (the standard UK supplement for pregnancies at high risk of NTD)and 1 g placebo

Group Type: PLACEBO_COMPARATOR

Folic acid and placebo

Intervention Type: DRUG

Folic acid and placebo

Interventions

Folic Acid and inositol

Folic Acid and inositol

Intervention Type: DRUG

Folic acid and placebo

Folic acid and placebo

Intervention Type: DRUG

Other Intervention Names

Study Group; Control Group

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

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Child Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Copp, Prof

Role: PRINCIPAL_INVESTIGATOR

Institute Of Child Health and Great Ormond Street Hospital

Locations

Neural Development Unit, Institute of Child Health

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

05ND07

Identifier Type: -

Identifier Source: org_study_id