Vitamin D Deficiency As a Risk Factor for the Development... | NCT06033105

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

NCT06033105

Sponsor

Fayoum University

Status

Completed

Last Update Posted

Nov 20, 2024Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Oral Lichen Planus
Vitamin D Deficiency

Interventions

ELISA

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2023Actual

Primary Completion Date

Aug 24, 2023Actual

Completion Date

Aug 24, 2023Actual

First Submitted Date

Sep 2, 2023

First Submission Date that Met QC Criteria

Sep 8, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2024

Last Update Posted Date

Nov 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		35 OLP patients	Device: ELISA
Group B		35 healthy controls.	Device: ELISA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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).

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Upon Request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017676	Lichen Planus, Oral
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D008010	Lichen Planus
D017512	Lichenoid Eruptions

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004797	Enzyme-Linked Immunosorbent Assay

Ancestor Terms

ID	Term
D007124	Immunoenzyme Techniques
D007118	Immunoassay
D007158	Immunologic Techniques
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided