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

NCT06033105 | Completed DMC

• 1 other identifier: 2191982
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Lichen Planus; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• serum vitamin D level in OLP

  measured by ELISA

  1 month

Secondary Outcomes (3)

• serum vitamin D level in correlation with sex, dietary habits and sun exposure.

  1 month

• serum vitamin D level in correlation with socioeconomic status

  1 month

• serum vitamin D level in correlation with Psychological factors

  1 month

Study Arms (2)

Group A

35 OLP patients

Device: ELISA

Group B

35 healthy controls.

Device: ELISA

Interventions

ELISA DEVICE

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 A; Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• (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.

You may not qualify if:

• (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).

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Lichen Planus, Oral; Vitamin D Deficiency

Interventions

Enzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Immunoenzyme Techniques; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunosorbent Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 2, 2023
• First Posted: September 13, 2023
• Study Start: August 1, 2023
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: November 20, 2024

Record last verified: 2023-09

Locations

EG (1)