The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level

NCT ID: NCT06204796

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-09-01

Brief Summary

The goal of this clinical trial is to compare between the use of vitamin D supplement in conjunction with systemic steroids versus the use of systemic steroids alone in the management of patients with symptomatic Oral Lichen Planus lesions and the comparison of salivary Interferon gamma levels in both study groups before and after treatment

Detailed Description

The objective of the research:

To investigate the role of vitamin D supplements in the management of vitamin D deficient oral lichen planus (OLP) patients and to examine its suppressive effect on pro-inflammatory cytokine (IFN-γ) in saliva samples of OLP patients

• Steps in short

1- Trial design: This study is a randomized clinical trial (RCT) having parallel groups with a 1:1 allocation ratio. This study will conform with the Consolidated Standards of Reporting Trials guidelines (CONSORT guidelines).

Middle-aged patients presenting with clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP (32) and having vitamin D deficiency or insufficiency (≤30 ng/ml) (33) will be included in the present study.

4-Intervention and study groups A total of 40 participants will be randomly and equally allocated into one of the two study groups to receive either, systemic steroids and vitamin D supplement (intervention) or systemic steroids only (control).

Clinical evaluation of the lesion through two components including objective morphological signs and subjective symptoms that describe the pain and burning sensation; will be measured at baseline and after 4 weeks of treatment

• Subjective findings (symptoms) using VAS score or burning sensation and pain ranging from 0 to 10 Changes in salivary INF-γ level (pg/mL) at baseline and after 4 weeks of treatment (measured using ELIZA technique)
• Treatment administration All participants will receive 40-60 mg of systemic prednisone as a single morning dose according to the severity. in the intervention group, a vitamin D supplement will be given as 60,000 IU weekly in conjunction with systemic steroids.

For the measurement of vitamin D3, The enzyme-linked immunosorbent assay (ELISA) will be used to process all samples simultaneously. Vitamin D levels lower than 30 ng/ml were assigned to vitamin D deficiency or insufficiency.

-Measurement of the inflammatory mediator (IFN-γ ) in saliva using (ELISA) kit After the initial diagnosis visit (during recruitment), patients will be clinically examined again for assessment of outcomes at baseline and after 1 month of treatment. Patients will be followed up for up to 60 days.

Conditions

Oral Lichen Planus; Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vitamin D+ Systemic steroids

vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids.

Group Type: ACTIVE_COMPARATOR

vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone

Intervention Type: DRUG

All participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case. In addition, a vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids.

Systemic prednisone

Intervention Type: DRUG

All participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case.

Systemic steroids alone

systemic steroids only

Group Type: ACTIVE_COMPARATOR

Systemic prednisone

Intervention Type: DRUG

All participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case.

Interventions

vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone

All participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case. In addition, a vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids.

Intervention Type: DRUG

Systemic prednisone

All participants received 40-60 mg of systemic prednisone as a single morning dose according to the severity of the condition until a 50% reduction in lesion size was achieved then the dose was tapered by 10mg each week and finally to 5 mg/day for the last week. Patients were followed up weekly for up to 60 days. The length and dose of treatment were adjusted according to clinical needs in each case.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Middle-aged patients
• Clinical and histopathological features of symptomatic (atrophic, erosive, or bullous) OLP
• Vitamin D deficiency or insufficiency (≤30 ng/ml)

Exclusion Criteria

• Oral mucosal lesion other than OLP
• Suspected restoration-related reaction
• Active periodontitis
• Patients receiving any topical or systemic medication that may affect SVDL or induce a lichenoid reaction
• Patient having systemic disease based on the detailed questionnaire of the modified Cornell Medical Index

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University

OTHER

Sponsor Role: lead

Responsible Party

Rania Hassan Shalby

Lecturer of Oral Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rania H Shalby

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry-Fayoum University

Yasmine G Hamid, phd

Role: PRINCIPAL_INVESTIGATOR

Modern modern university for technology and information MTI University

Locations

Rania Hassan Shalby

Giza, , Egypt

Countries

Egypt

Other Identifiers

19038219038211013

Identifier Type: -

Identifier Source: org_study_id