Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth

Gingival Overgrowth Clinical Trial

— PIGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781196
• Other study ID #: PIGO
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2008
• Last updated: August 3, 2009
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Gingival Hyperplasia
• Gingival Overgrowth

Intervention

Drug:
• folic acid
capsule 0.5 mg once a day
• placebo
capsule, once a day

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy		6 months	No
Secondary	Occurrence of grade > 2 hyperplasia at the end of 6 mo		6 months	No
Secondary	Time to occurrence of grade > 2 overgrowth		open	No
Secondary	Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index		6 months	No