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Sponsored by: |
Institute of Child Health |
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Information provided by: | Institute of Child Health |
ClinicalTrials.gov Identifier: | NCT00452829 |
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 |
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Recurrent Neural Tube Defects |
Drug: Folic Acid and inositol Drug: Folic acid and placebo |
Phase I |
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) |
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contact: Mrs K Burren | 0207 905 2326 | ponti@ich.ucl.ac.uk |
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 |
Principal Investigator: | Andrew Copp, Prof | Institute Of Child Health and Great Ormond Street Hospital |
Study ID Numbers: | 05ND07 |
Study First Received: | March 27, 2007 |
Last Updated: | March 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00452829 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Neural Tube Defects Vitamin B Complex Nervous System Malformations Hematinics Inositol Folate Trace Elements Folinic Acid |
Vitamin B9 Recurrence Folic Acid Vitamins Micronutrients Congenital Abnormalities Neural Tube Defect, Folate-sensitive |
Neural Tube Defects Vitamin B Complex Nervous System Malformations Hematinics Growth Substances Hematologic Agents Nervous System Diseases Inositol |
Physiological Effects of Drugs Pharmacologic Actions Folic Acid Therapeutic Uses Vitamins Micronutrients Congenital Abnormalities |