NCT00781196

Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth

Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: All India Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 6 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gingival Overgrowth

Interventions

Type	Name	Description
DRUG	folic acid	capsule 0.5 mg once a day
DRUG	placebo	capsule, once a day

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-01-01
• Completion: 2009-07-01
• First posted: 2008-10-28
• Last updated: 2009-08-04

Locations

1 site across 1 country: India