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Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth (PIGO)

Primary Purpose

Gingival Overgrowth

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
folic acid
placebo
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gingival Overgrowth focused on measuring phenytoin, gum hyperplasia, phenytoin induced gingival overgrowth, plaque index, gingival overgrowth grade

Eligibility Criteria

6 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Oral folic acid

placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Occurrence of grade > 2 hyperplasia at the end of 6 mo
Time to occurrence of grade > 2 overgrowth
Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index

Full Information

First Posted
October 27, 2008
Last Updated
August 3, 2009
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT00781196
Brief Title
Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth
Acronym
PIGO
Official Title
Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Overgrowth
Keywords
phenytoin, gum hyperplasia, phenytoin induced gingival overgrowth, plaque index, gingival overgrowth grade

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Oral folic acid
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
folic acid
Intervention Description
capsule 0.5 mg once a day
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
capsule, once a day
Primary Outcome Measure Information:
Title
Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Occurrence of grade > 2 hyperplasia at the end of 6 mo
Time Frame
6 months
Title
Time to occurrence of grade > 2 overgrowth
Time Frame
open
Title
Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
21482950
Citation
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.
Results Reference
derived

Learn more about this trial

Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth

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