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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00452829
First received: March 27, 2007
Last updated: June 23, 2015
Last verified: June 2015
  Purpose

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 Intervention Phase
Recurrent Neural Tube Defects
Drug: Folic Acid and inositol
Drug: Folic acid and placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)

Resource links provided by NLM:


Further study details as provided by Institute of Child Health:

Enrollment: 100
Study Start Date: September 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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 .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452829

Locations
United Kingdom
Neural Development Unit, Institute of Child Health
London, United Kingdom, WC1N 1EH
Sponsors and Collaborators
Institute of Child Health
Investigators
Principal Investigator: Andrew Copp, Prof Institute Of Child Health and Great Ormond Street Hospital
  More Information

No publications provided

Responsible Party: Institute of Child Health
ClinicalTrials.gov Identifier: NCT00452829     History of Changes
Other Study ID Numbers: 05ND07
Study First Received: March 27, 2007
Last Updated: June 23, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Neural Tube Defects
Spinal Dysraphism
Congenital Abnormalities
Nervous System Diseases
Nervous System Malformations
Folic Acid
Inositol
Vitamin B Complex
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins

ClinicalTrials.gov processed this record on July 05, 2015