NCT00781196CompletedPhase 3

Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.

All India Institute of Medical Sciences, New Delhi1 site in 1 country120 target enrollmentStarted: May 2008Last updated: August 4, 2009

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor
Enrollment: 120
Locations: 1
Primary Endpoint: Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Prevention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 6 Years to 15 Years (Child)
Sex: All
Accepts Healthy Volunteers: No

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

Arms & Interventions

1

Experimental

Oral folic acid

Intervention: folic acid (Drug)

2

Placebo Comparator

placebo

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy

Time Frame: 6 months

Secondary Outcomes

Occurrence of grade > 2 hyperplasia at the end of 6 mo(6 months)
Time to occurrence of grade > 2 overgrowth(open)
Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index(6 months)

Investigators

Sponsor

All India Institute of Medical Sciences, New Delhi

Sponsor Class

Other

Study Sites (1)

Loading locations...

Similar Trials

Not yet recruiting

Phase 2

Clinical study of folic acid supplementation on gum health in subjects undergoing orthodontic treatment

CTRI/2024/03/064247Dr Iman Ahmad

Recruiting

Phase 1

The effect of oral folinic acid to prevent pemetrexed induced adverse events.on small cell lung cancer (NSCLC), Mesothelioma, ThymomaMedDRA version: 20.0Level: PTClassification code: 10027406Term: Mesothelioma Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10059515Term: Non-small cell lung cancer metastatic Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864MedDRA version: 20.0Level: PTClassification code: 10043670Term: Thymoma Class: 100000004864

CTIS2022-502345-10-00Amphia Hospital50

Recruiting

Phase 3

Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth (PIGO)

CTRI/2008/091/000227AIIMS120

Completed

Phase 1

Effects of oral isotertinoin on folic acid, homocysteine and biochemical and hematological markers in acne vulgaris patientsacne vulgaris.

IRCT2012103011316N1orestan University of Medical Sciences44

Completed

Phase 3

The Effect of Folic Acid Mouthwash on Stomatitis Caused by Head and Neck radiotherapy

IRCT20180526039847N1Mashhad University of Medical Sciences100