CompletedPhase 3

Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth

India120 participantsStarted 2008-05

Plain-language 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.

Who can participate

Age range6 Years – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 6-15 yr * Started on phenytoin within 1 mo of enrollment Exclusion Criteria: * 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

What they're measuring

Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy

Timeframe: 6 months

Trial details

NCT IDNCT00781196

SponsorAll India Institute of Medical Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-01

View on ClinicalTrials.gov More Gingival Overgrowth trials