Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth - Full Text View

Sponsored by:	All India Institute of Medical Sciences, New Delhi
Information provided by:	All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:	NCT00781196

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 III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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: Dietary Supplements

Drug Information available for: Phenytoin Folic acid Phenytoin sodium

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
1: Experimental Oral folic acid	Drug: folic acid capsule 0.5 mg once a day
2: Placebo Comparator 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, Delhi
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

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

Study placed in the following topic categories:

Mouth Diseases
Gingival Diseases
Vitamin B Complex
Hematinics
Folate
Trace Elements
Folinic Acid
Vitamin B9
Folic Acid

Phenytoin
Hyperplasia
Periodontal Diseases
Vitamins
Stomatognathic Diseases
Micronutrients
Gingival Overgrowth
Anticonvulsants

Additional relevant MeSH terms:

Mouth Diseases
Gingival Diseases
Vitamin B Complex
Hematinics
Growth Substances
Hematologic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Folic Acid

Phenytoin
Periodontal Diseases
Therapeutic Uses
Vitamins
Micronutrients
Stomatognathic Diseases
Gingival Overgrowth
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on September 01, 2009