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

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

To examine how a lack of vitamin D may increase the risk of developing oral lichen planus and its malignant progression while accounting for sex, food habits, sunlight, socioeconomic level, and psychological variables.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Oral Lichen Planus
• Intervention / Treatment: Device: ELISA

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Egypt
  • Fayoum, Egypt
    • Fayoum University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients presenting with a clinical picture and histological findings that confirm the diagnosis of OLP (Group A) and age, sex, and dietary habits matched healthy controls (Group B).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; 35 OLP patients	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.
Group B; 35 healthy controls.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum vitamin D level in OLP	measured by ELISA	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fayoum University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): August 24, 2023
• Study Completion (Actual): August 24, 2023

Study Registration Dates

• First Submitted: September 2, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Nutrition Disorders; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Lichen Planus, Oral; Lichen Planus; Vitamin D Deficiency
• Other Study ID Numbers: 2191982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Upon Request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No