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

October 27, 2008
August 3, 2009
May 2008
January 2009   (final data collection date for primary outcome measure)
Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00781196 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Gingival Overgrowth
  • Drug: folic acid
    capsule 0.5 mg once a day
  • Drug: placebo
    capsule, once a day
  • Experimental: 1
    Oral folic acid
    Intervention: Drug: folic acid
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
July 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00781196
PIGO
Yes
Ravindra Arya, All India Institute of Medical Sciences, New Delhi
All India Institute of Medical Sciences, New Delhi
Not Provided
Not Provided
All India Institute of Medical Sciences, New Delhi
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP