Gingival OvergrowthPhase 3PIGONCT00781196
Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth
A Phase 3 study testing folic acid in people with Gingival Overgrowth, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Gingival Overgrowth
- What is being tested?
- folic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- May 2008to Jul 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6-15 yr
- Started on phenytoin within 1 mo of enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.
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.
- Conditions
- Gingival Overgrowth
- Being tested
- folic acid, placebo
- Keywords
- phenytoin, gum hyperplasia, phenytoin induced gingival overgrowth, plaque index, gingival overgrowth grade
- Medical subject headings
- Gingival Overgrowth, Gingival Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
folic acidDrug
capsule 0.5 mg once a day
placeboDrug
capsule, once a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral folic acid Receives: Drug: folic acid |
| 2 | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy
Measured: 6 months
Secondary outcomes (3)
Occurrence of grade > 2 hyperplasia at the end of 6 mo
Measured: 6 months
Time to occurrence of grade > 2 overgrowth
Measured: open
Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival OvergrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781196
- Sponsor's protocol ID
- PIGO
- Acronym
- PIGO
- Status last verified
- Aug 2009
- First submitted
- 27 Oct 2008
- Last updated
- 4 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21482950
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Dose Oral Folic Acid Supplementation on Phenytoin Induced Gingival Overgrowth: A Randomized Double Blind Controlled Trial.
- ClinicalTrials.gov ID
- NCT00781196
- Acronym / sponsor ID
- PIGO / PIGO
- Conditions
- Gingival Overgrowth
- Keywords
- phenytoin, gum hyperplasia, phenytoin induced gingival overgrowth, plaque index, gingival overgrowth grade
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 28 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: folic acidOral folic acid |
| 2 | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age: 6-15 yr
- Started on phenytoin within 1 mo of enrollment
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| folic acidcapsule 0.5 mg once a day | Drug | 1 |
| placebocapsule, once a day | Drug | 2 |
Primary outcome
Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy
Time frame: 6 months
3 secondary outcomes
Occurrence of grade > 2 hyperplasia at the end of 6 mo
Time frame: 6 months
Time to occurrence of grade > 2 overgrowth
Time frame: open
Correlation between following and occurrence of grade > 2 overgrowth *phenytoin dose (in mg/kg/d) *serum phenytoin levels *plaque index
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2009.
- Derived from this study: PubMed 21482950Arya 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing folic acid in people with Gingival Overgrowth, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of any grade of overgrowth in 2 groups after 6 mo of phenytoin therapy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00781196, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2009.