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Trial record 2 of 52 for:    "Neural tube defects"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Institute of Child Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00452829
First received: March 27, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

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
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

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

No publications provided

ClinicalTrials.gov Identifier: NCT00452829     History of Changes
Other Study ID Numbers: 05ND07
Study First Received: March 27, 2007
Last Updated: March 27, 2007
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 November 20, 2014