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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

Tracking Information
First Submitted Date April 16, 2020
First Posted Date April 21, 2020
Last Update Posted Date April 24, 2020
Actual Study Start Date January 1, 2020
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2020)
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vitamin D and Its Receptor Gene Polymorphisms in Lithuanian, Latvian and Taiwanese Patients With Atopic Dermatitis and Asthma
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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Atopic Dermatitis
  • Asthma
Intervention
  • 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.
Study Groups/Cohorts
  • Atopic dermatitis
    Interventions:
    • Diagnostic Test: Peripheral vein punction
    • Diagnostic Test: Stool collection
  • Asthma
    Interventions:
    • Diagnostic Test: Peripheral vein punction
    • Diagnostic Test: Stool collection
  • Healthy individuals
    Interventions:
    • Diagnostic Test: Peripheral vein punction
    • Diagnostic Test: Stool collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: April 18, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages up to 60 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Lithuania
Removed Location Countries  
 
Administrative Information
NCT Number NCT04354207
Other Study ID Numbers LLTADA
S-LLT-20-1 ( Other Grant/Funding Number: Researh Council of Lithuania )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Brigita Sitkauskiene, Lithuanian University of Health Sciences
Study Sponsor Lithuanian University of Health Sciences
Collaborators Research Council of Lithuania
Investigators
Principal Investigator: Brigita Sitkauskiene, Prof. Lithuanian University of Health Sciences
PRS Account Lithuanian University of Health Sciences
Verification Date April 2020