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Trial record 6 of 13 for:    asthma | Recruiting, Not yet recruiting, Active, not recruiting, Enrolling by invitation Studies | "vitamin d"

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

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ClinicalTrials.gov Identifier: NCT04354207
Recruitment Status : Enrolling by invitation
First Posted : April 21, 2020
Last Update Posted : April 24, 2020
Sponsor:
Collaborator:
Research Council of Lithuania
Information provided by (Responsible Party):
Brigita Sitkauskiene, Lithuanian University of Health Sciences

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.


Condition or disease Intervention/treatment
Atopic Dermatitis Asthma Diagnostic Test: Peripheral vein punction Diagnostic Test: Stool collection

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atopic dermatitis Diagnostic Test: Peripheral vein punction
Vitamin D level, vitamin D receptor genetic polymorphisms, allergen specific IgE and total IgE will be measured in peripheral blood

Diagnostic Test: Stool collection
Gut microbiome will be investigated in stool samples.

Asthma Diagnostic Test: Peripheral vein punction
Vitamin D level, vitamin D receptor genetic polymorphisms, allergen specific IgE and total IgE will be measured in peripheral blood

Diagnostic Test: Stool collection
Gut microbiome will be investigated in stool samples.

Healthy individuals Diagnostic Test: Peripheral vein punction
Vitamin D level, vitamin D receptor genetic polymorphisms, allergen specific IgE and total IgE will be measured in peripheral blood

Diagnostic Test: Stool collection
Gut microbiome will be investigated in stool samples.




Primary Outcome Measures :
  1. Vitamin D level in serum in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan [ Time Frame: 2nd year of study ]
    Comparison of serum vitamin D level (25(OH)D) by ELISA between studied groups

  2. Vitamin D receptors (VDRs) genetic polymorphisms in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan [ Time Frame: 2nd year of study ]
    Comparison of VDRs genetic polymorphisms using genetic evaluation between studied groups

  3. Composition of gut microbiome in patients with atopic dermatitis, asthma and healthy individuals from Lithuania, Latvia and Taiwan [ Time Frame: 3rd year of study ]
    Investigation and comparison of gut microbiome using genetic evaluation between studied groups



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Ages Eligible for Study:   up to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04354207


Locations
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Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania
Sponsors and Collaborators
Lithuanian University of Health Sciences
Research Council of Lithuania
Investigators
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Principal Investigator: Brigita Sitkauskiene, Prof. Lithuanian University of Health Sciences
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Responsible Party: Brigita Sitkauskiene, Prof., Head of Department of Immunology and Allergology, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT04354207    
Other Study ID Numbers: LLTADA
S-LLT-20-1 ( Other Grant/Funding Number: Researh Council of Lithuania )
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Dermatitis, Atopic
Dermatitis
Eczema
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous