Asthma Clinical Trial
Official title:
Comparative Study of Vitamin D and Its Receptor Gene Polymorphisms in Lithuanian, Latvian, and Taiwanese Children and Adults With Atopic Dermatitis and Asthma
Verified date | April 2020 |
Source | Lithuanian University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 500 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 1, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 60 Years |
Eligibility |
Inclusion Criteria: - Patients with mild to moderate asthma - Patients with mild to moderate atopic dermatitis - Healthy individuals Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Lithuania | Hospital of Lithuanian University of Health Sciences Kauno klinikos | Kaunas |
Lead Sponsor | Collaborator |
---|---|
Lithuanian University of Health Sciences | Research Council of Lithuania |
Lithuania,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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