Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth

NCT ID: NCT00781196

Last Updated: 2009-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-07-31

Brief Summary

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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

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Conditions

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Gingival Overgrowth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Oral folic acid

Group Type EXPERIMENTAL

folic acid

Intervention Type DRUG

capsule 0.5 mg once a day

2

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

capsule, once a day

Interventions

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folic acid

capsule 0.5 mg once a day

Intervention Type DRUG

placebo

capsule, once a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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All India Institute of Medical Sciences, New Delhi

Locations

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All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 21482950 (View on PubMed)

Other Identifiers

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PIGO

Identifier Type: -

Identifier Source: org_study_id

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