Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth (PIGO)

This study has been completed.

Sponsor:

Information provided by:

All India Institute of Medical Sciences, New Delhi

ClinicalTrials.gov Identifier:

NCT00781196

First received: October 27, 2008

Last updated: August 3, 2009

Last verified: August 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	October 27, 2008
Last Updated Date	August 3, 2009
Start Date ^ICMJE	May 2008
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 27, 2008)	Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00781196 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 27, 2008)	Occurrence of grade > 2 hyperplasia at the end of 6 mo [ Time Frame: 6 months ] [ Designated as safety issue: No ] Time to occurrence of grade > 2 overgrowth [ Time Frame: open ] [ Designated as safety issue: No ] Correlation between following and occurrence of grade > 2 overgrowth phenytoin dose (in mg/kg/d) serum phenytoin levels *plaque index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth
Official Title ^ICMJE	Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Gingival Overgrowth
Intervention ^ICMJE	Drug: folic acid capsule 0.5 mg once a day Drug: placebo capsule, once a day
Study Arm (s)	Experimental: 1 Oral folic acid Intervention: Drug: folic acid Placebo Comparator: 2 placebo Intervention: Drug: placebo
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	120
Completion Date	July 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	6 Years to 15 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	India

Administrative Information
NCT Number ^ICMJE	NCT00781196
Other Study ID Numbers ^ICMJE	PIGO
Has Data Monitoring Committee	Yes
Responsible Party	Ravindra Arya, All India Institute of Medical Sciences, New Delhi
Study Sponsor ^ICMJE	All India Institute of Medical Sciences, New Delhi
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	All India Institute of Medical Sciences, New Delhi
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top