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

The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level: a Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Oral Lichen Planus
• Intervention / Treatment: Drug: vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone; Drug: Systemic prednisone

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Rania Hassan Shalby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin D+ Systemic steroids; vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic steroids.	Drug: 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.; 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.
Active Comparator: Systemic steroids alone; systemic steroids only	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of clinical presentation of the lesion	The severity of the clinical presentation of the lesion was calculated by multiplying (Sub-site score A) by (Severity score B) as Sub-site score A 0= no lesion; evidence of lichen planus; ≥50% of buccal mucosa, dorsum of the tongue, the floor of the mouth, hard palate, soft palate, or oropharynx affected Severity score B 0= keratosis only; keratosis with mild erythema (≤ 3 mm from gingival margin); marked erythema (e.g. full thickness of gingivae, extensive with atrophy or edema on non-keratinized mucosa); ulceration present Severity of clinical appearance=A*B (sub-site score* severity score)Mild: 1-2Moderate: 3-4Severe: 5-6 Finally, the lesion was considered as persisting at follow-up if the clinical presentation score was greater than 0 where whereas a score of 0 indicated a healed lesion.	1 months
Pain and burning sensation	VAS score or burning sensation and pain ranging from 0 to 10; Mild : 0-4; Moderate: 5-7; Severe: 8-10	1 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in salivary INF-γ level	Changes in salivary INF-γ level (pg/mL) at baseline and after 4 weeks of treatment (measured using ELIZA technique)	1 months

Collaborators and Investigators

• Sponsor: Fayoum University
• Investigators: Principal Investigator: Rania H Shalby, Faculty of Dentistry-Fayoum University; Principal Investigator: Yasmine G Hamid, phd, Modern modern university for technology and information MTI University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: September 10, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: vitamin D, Oral Lichen Planus, salivary IFN-γ
• Additional Relevant MeSH Terms: Skin Diseases; Nutrition Disorders; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Avitaminosis; Deficiency Diseases; Malnutrition; Lichenoid Eruptions; Vitamin D Deficiency; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Prednisone
• Other Study ID Numbers: 19038219038211013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No