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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
  Purpose

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.


Condition Intervention Phase
Gingival Overgrowth
 Drug: folic acid
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins
U.S. FDA Resources

Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: May 2008
Study Completion Date: July 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Oral folic acid
 Drug: folic acid
capsule 0.5 mg once a day
Placebo Comparator: 2
placebo
 Drug: placebo
capsule, once a day

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781196

Locations
India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
  More Information

No publications provided by All India Institute of Medical Sciences, New Delhi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ravindra Arya, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT00781196     History of Changes
Other Study ID Numbers: PIGO
Study First Received: October 27, 2008
Last Updated: August 3, 2009
Health Authority: India: Ministry of Health

Keywords provided by All India Institute of Medical Sciences, New Delhi:
phenytoin
gum hyperplasia
phenytoin induced gingival overgrowth
plaque index
gingival overgrowth grade

Additional relevant MeSH terms:
Gingival Overgrowth
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Phenytoin
Folic Acid
Vitamin B Complex
Hematinics
 Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematologic Agents

ClinicalTrials.gov processed this record on May 19, 2013