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

This study is currently recruiting participants.
Verified by Institute of Child Health, March 2007

Sponsored by: Institute of Child Health
Information provided by: Institute of Child Health
ClinicalTrials.gov Identifier: NCT00452829
  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 I

MedlinePlus related topics:   Neural Tube Defects   

ChemIDplus related topics:   Folic acid    Inositol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:   Prevention of Neural Tube Defects by Inositol in Conjunction With Folic Acid (PONTI Study)

Further study details as provided by Institute of Child Health:

Estimated Enrollment:   100

  Eligibility
Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Women with a history of one or more isolated neural tube defects (spina bfida, anencephaly or encepalcele) who wish to embark ipon a further pregnancy
  Contacts and Locations

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

Contacts
Contact: Mrs K Burren     0207 905 2326     ponti@ich.ucl.ac.uk    

Locations
United Kingdom
Neural Development Unit, Institute of Child Health     Recruiting
      London, United Kingdom, WC1N 1EH
      Contact: Katie Burren     0207 905 2326        
      Principal Investigator: Andrew Copp, Prof            

Sponsors and Collaborators
Institute of Child Health

Investigators
Principal Investigator:     Andrew Copp, Prof     Institute Of Child Health and Great Ormond Street Hospital    
  More Information


Study ID Numbers:   05ND07
First Received:   March 27, 2007
Last Updated:   March 27, 2007
ClinicalTrials.gov Identifier:   NCT00452829
Health Authority:   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Folic Acid
Neural Tube Defects
Nervous System Malformations
Inositol
Neural tube defect, folate-sensitive
Congenital Abnormalities
Recurrence

Additional relevant MeSH terms:
Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins
Hematologic Agents
Physiological Effects of Drugs
Nervous System Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 20, 2008




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