Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204796
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2023-09-10
Brief Title:
The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level
Sponsor:
Fayoum University
Organization:
Fayoum University
Study Overview
Official Title:
The Role of Vitamin D in Amelioration of Oral Lichen Planus and Its Effect on Salivary IFN-γ Level a Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 ngml 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 pgmL 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 60000 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 ngml 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
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 11 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 ngml 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 pgmL 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 60000 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 ngml 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None