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NCT06033105 Clinical Trial

Vitamin D Deficiency as a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus

Vitamin D Deficiency Clinical Trial

Official title:
Vitamin D Deficiency as a Risk Factor for the Development and Malignant Transformation of Oral Lichen Planus: a Case-control Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06033105
Other study ID # 2191982
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2023
Est. completion date August 24, 2023

Study information
Verified date September 2023
Source Fayoum University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To investigate the role of Vitamin D (VD) deficiency as a risk factor for the development and malignant transformation of Oral lichen planus (OLP) taking into consideration sex, dietary habits, sun exposure, socioeconomic status and psychological factors.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date August 24, 2023
Est. primary completion date August 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - (Group A) patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP - (Group B) age, sex, and dietary habits matched healthy controls. Exclusion Criteria: - (1) subjects who have been receiving any kind of VD supplements, multivitamins, or any drug that may affect VD measurements - (2) patients with suspected restoration-related or smokeless tobacco-related lesions. - (3) patients with any systemic medical condition or pregnant females. - (4) patients with VD toxicity (VD=100 ng/ml).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• ELISA
Enzyme-linked immunosorbent assay (ELISA) was used following manufacturer's instructions. This test uses a competitive ELISA-based technique that was designed to quantitatively determine the concentration of 1,25-dihydroxyvitamin D3/D2 in human serum.

Locations
Country Name City State
Egypt Fayoum University Fayoum

Sponsors (1)
Lead Sponsor Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum vitamin D level in OLP measured by ELISA 1 month
Secondary serum vitamin D level in correlation with sex, dietary habits and sun exposure. Questionnaire, measured in proportions 1 month
Secondary serum vitamin D level in correlation with socioeconomic status Kuppuswamy's socioeconomic status scale 1 month
Secondary serum vitamin D level in correlation with Psychological factors Depression Anxiety and Stress Scale 21 (DASS-21) 1 month
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