Status:
UNKNOWN
Folic Acid Dosage and Malformations Reduction
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Collaborating Sponsors:
International Centre of Birth Defects
Conditions:
Congenital Malformations
Eligibility:
FEMALE
18-44 years
Phase:
PHASE3
Brief Summary
In 1991 the Medical Research Council Vitamin Study Group and in 1992 the Hungarian randomised clinical trial have shown conclusively that the risk of neural tube defects can be reduced substantially b...
Eligibility Criteria
Inclusion
- age between 18 and 44 years
- women who intend to become pregnant (not excluded women
Exclusion
- pregnant women
- women planning to move to an area where the study is not ongoing
- women who do not understand and speak Italian
- women who do not have a phone
- women affected by epilepsy, even not assuming anticonvulsivant drugs
- women affected by diabetes
- women who previously had a tumour or a disease relevant for the study (Crohn disease, rheumatoid arthritis, ulcerative colitis)
- women who recently assumed antifolates, like methotrexate
- women who currently abuse or previously abused alcohol
- obese women
- vegetarian women
- women who had a previous pregnancy with neural tube defect (NTD) or any other congenital structural defect
- women or partners with NTD, or one of their relatives with an NTD
- women with positive family history for breast or colorectal cancer
- women with positive family or personal history of hereditary syndrome like adenomatous polyposis, or hereditary nonpolyposis colorectal cancer
- women allergic to folic acid
- women presenting contraindications to folic acid
- women affected by megaloblastic anaemia
- assuming folic acid at defined doses for conditions other than those already mentioned
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2016
Estimated Enrollment :
5000 Patients enrolled
Trial Details
Trial ID
NCT01244347
Start Date
July 1 2009
End Date
September 1 2016
Last Update
January 14 2015
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale di Adria
Adria, Rovigo, Italy, 45011
2
Ospedale San Luca
Trecenta, Rovigo, Italy, 45027
3
Ospedale di Conegliano
Conegliano, Treviso, Italy, 31015
4
Family Health Centre
Montebelluna, Treviso, Italy, 31044