Vitamin D and Its Receptor Gene Polymorphisms in Lithuanian, Latvian and Taiwanese Patients With Atopic Dermatitis and Asthma

NCT04354207 | Unknown

• 2 other identifiers: LLTADAS-LLT-20-1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The role of vitamin D is well known in calcium and phosphate homeostasis; however, in addition to traditional functions, vitamin D has an important role in pathogenesis of different allergic diseases, such as asthma, atopic dermatitis (AD), and food allergy. There are evidences that lower cord blood vitamin D status is observed in infants with eczema. More-over, vitamin D level is decreased in subjects with asthma. One of the most important functions of vitamin D is to modulate the immune system response, both innate and adaptive, by suppressing Th2-type response and increasing natural killer cells. Vitamin D induces a higher level of IL-10, which is known as anti-inflammatory cytokine. Other studies have shown that vitamin D contributes to the conversion of CD4+ T cells to T regulatory cells. Recent studies showed that higher serum 25-hydroxyvitamin D level was associated with a reduced risk of asthma exacerbation and hospitalization. Vitamin D can enhance dexamethasone-induced MAP kinase phosphatase-1 (MKP-1) expression in peripheral blood mononuclear cells. Experimental data suggest that vitamin D can potentially increase the therapeutic response to glucocorticoid and can be used as an add-on treatment in steroid-resistant asthmatics. Vitamin D stimulates the production and regulation of skin antimicrobial peptides, such as cathelicidins, which have both direct antimicrobial activity and induced host cellular response by triggering cytokine release. Recent evidence suggests that low blood vitamin D level is a risk factor for food allergy. Vitamin D acts by binding to the vitamin D receptors (VDRs), which are located in a variety of tissues. VDRs have been identified on nearly all cells of the immune system including T cells, B cells, neutrophils, macrophages, and dendritic cells (DCs). Vitamin D deficiency predisposes to gastrointestinal infections by changing gut micro-biota, which may promote the development of food allergy. However the detail mechanism how vitamin D affects or protects the development of allergic diseases is still unknown. Vitamin D level is determined by sun exposure. Due to the fact that Lithuania, Latvia and Taiwan are located in different latitudes of north hemisphere with markedly different sun exposure, in this Joint collaboration study between Taiwan, Lithuanian and Latvia, we are going to study, (1). Serum vitamin D level in children and adults with AD and/or asthma in Lithuania, Latvia and Taiwan. (2). VDRs genetic polymorphisms of AD and/or asthma in children and adults in Lithuania, Latvia and Taiwan. (3). Finally, we would like to explore the gut microbiome of patients with AD and/or asthma in Lithuanian, Latvian and Taiwanese children and adults; and to estimate possible relationship between gut microbiome and vitamin D level and VDRs genetic polymorphisms. We believe that this study will be the first which compares the populations with different geographical and ecological factors having the same allergic diseases. We hope that these results will provide the answer about the role of vitamin D in the prevention, or in the future, in treatment of allergic diseases.

Conditions

Atopic Dermatitis; Asthma

Outcome Measures

Primary Outcomes (3)

• Vitamin D level in serum in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan

  Comparison of serum vitamin D level (25(OH)D) by ELISA between studied groups

  2nd year of study

• Vitamin D receptors (VDRs) genetic polymorphisms in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan

  Comparison of VDRs genetic polymorphisms using genetic evaluation between studied groups

  2nd year of study

• Composition of gut microbiome in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan

  Investigation and comparison of gut microbiome using genetic evaluation between studied groups

  3rd year of study

Study Arms (3)

Atopic dermatitis

Diagnostic Test: Peripheral vein punction; Diagnostic Test: Stool collection

Asthma

Diagnostic Test: Peripheral vein punction; Diagnostic Test: Stool collection

Healthy individuals

Diagnostic Test: Peripheral vein punction; Diagnostic Test: Stool collection

Interventions

Peripheral vein punction DIAGNOSTIC_TEST

Vitamin D level, vitamin D receptor genetic polymorphisms, allergen specific IgE and total IgE will be measured in peripheral blood

Asthma; Atopic dermatitis; Healthy individuals

Stool collection DIAGNOSTIC_TEST

Gut microbiome will be investigated in stool samples.

Asthma; Atopic dermatitis; Healthy individuals

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children and adults with mild to moderate asthma or mild to moderate atopic dermatits. Healthy individuals as control group.

You may qualify if:

• Patients with mild to moderate asthma
• Patients with mild to moderate atopic dermatitis
• Healthy individuals

You may not qualify if:

• Acute or chronic infections
• Oncological diseases
• Acute systemic autoimmune diseases
• Use of systemic immunosuppressants (wait 1 month)
• Use of vitamin D supplementation
• Use of systemic antihistamines (wait 1 week)

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Research Council of Lithuania: collaborator

Study Sites (1)

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, Lithuania

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Asthma

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity

Study Officials

• Brigita Sitkauskiene, Prof.

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof., Head of Department of Immunology and Allergology

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 21, 2020
• Study Start: January 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: December 31, 2022
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)