Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth
NCT ID: NCT00781196
Last Updated: 2009-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2008-05-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
Oral folic acid
folic acid
capsule 0.5 mg once a day
2
placebo
placebo
capsule, once a day
Interventions
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folic acid
capsule 0.5 mg once a day
placebo
capsule, once a day
Eligibility Criteria
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Inclusion Criteria
* Started on phenytoin within 1 mo of enrollment
Exclusion Criteria
* On other folic acid antagonists e.g. anti-neoplastic drugs for \>/= 2 wks during last 3 months
* Pre-existing gingival over-growth due to other cause
6 Years
15 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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All India Institute of Medical Sciences, New Delhi
Locations
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All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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References
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Arya R, Gulati S, Kabra M, Sahu JK, Kalra V. Folic acid supplementation prevents phenytoin-induced gingival overgrowth in children. Neurology. 2011 Apr 12;76(15):1338-43. doi: 10.1212/WNL.0b013e3182152844.
Other Identifiers
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PIGO
Identifier Type: -
Identifier Source: org_study_id
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