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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Folic Acid
Phenytoin
Vitamin B Complex
Anticonvulsants
Cardiovascular Agents
Central Nervous System Agents
Growth Substances
Hematinics
Hematologic Agents
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Vitamins
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 21, 2014