The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level
Condition: Oral Lichen Planus; Vitamin D Deficiency
MeSH terms: Lichen Planus, Oral; Lichen Planus; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): vitamin D supplement was given as 60,000 IU weekly in conjunction with systemic prednisone; Systemic prednisone
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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 MeSH terms: Vitamin D; Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin D, Oral Lichen Planus, salivary IFN-γ