Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth
PIGO
Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.
1 other identifier
interventional
120
1 country
1
Brief Summary
Phenytoin, a common anti-seizure drug, leads to cosmetically unacceptable side effect of gingival overgrowth in a significant number of patients. There is some evidence of therapeutic effect of folic acid in cases of established phenytoin induced gingival overgrowth. In this study, the aim is to study the prospective preventive effect of low dose oral folic acid supplementation on phenytoin induced gingival overgrowth in epileptic children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2008
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 27, 2008
CompletedFirst Posted
Study publicly available on registry
October 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedAugust 4, 2009
August 1, 2009
8 months
October 27, 2008
August 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy
6 months
Secondary Outcomes (3)
Occurrence of grade > 2 hyperplasia at the end of 6 mo
6 months
Time to occurrence of grade > 2 overgrowth
open
Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index
6 months
Study Arms (2)
1
EXPERIMENTALOral folic acid
2
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- Age: 6-15 yr
- Started on phenytoin within 1 mo of enrollment
You may not qualify if:
- Not willing to participate
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
Related Publications (1)
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.
PMID: 21482950DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 27, 2008
First Posted
October 28, 2008
Study Start
May 1, 2008
Primary Completion
January 1, 2009
Study Completion
July 1, 2009
Last Updated
August 4, 2009
Record last verified: 2009-08