Atopic DermatitisNCT04354207
Vitamin D and Its Receptor Gene Polymorphisms in Lithuanian, Latvian and Taiwanese Patients With Atopic Dermatitis and Asthma
An observational study of Atopic Dermatitis and Asthma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Atopic Dermatitis, Asthma
- What is being tested?
- Peripheral vein punction and Stool collection
- How many people
- 500 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- Child, Adult
Study population: Children and adults with mild to moderate asthma or mild to moderate atopic dermatits. Healthy individuals as control group.
Who may be able to join
- Patients with mild to moderate asthma
- Patients with mild to moderate atopic dermatitis
- Healthy individuals
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas
About this study
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
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).
Read more
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
- Being tested
- Peripheral vein punction, Stool collection
- Medical subject headings
- Dermatitis, Atopic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral vein punctionDiagnostic test
Vitamin D level, vitamin D receptor genetic polymorphisms, allergen specific IgE and total IgE will be measured in peripheral blood
Stool collectionDiagnostic test
Gut microbiome will be investigated in stool samples.
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis | Not described Receives: Diagnostic Test: Peripheral vein punction; Diagnostic Test: Stool collection | |
| Asthma | Not described Receives: Diagnostic Test: Peripheral vein punction; Diagnostic Test: Stool collection | |
| Healthy individuals | Not described Receives: Diagnostic Test: Peripheral vein punction; Diagnostic Test: Stool collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3rd year of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Jan 2020
- Primary completion1 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Research Council of Lithuania
- Responsible party
- Principal investigator, Brigita Sitkauskiene, Lithuanian University of Health Sciences
- Investigators
- Brigita Sitkauskiene, Prof., Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354207
- Sponsor's protocol ID
- LLTADA
- Other IDs
- S-LLT-20-1
- Status last verified
- Apr 2020
- First submitted
- 16 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04354207
- Acronym / sponsor ID
- LLTADA
- Conditions
- Atopic Dermatitis, Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Research Council of Lithuania
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and adults with mild to moderate asthma or mild to moderate atopic dermatits. Healthy individuals as control group.
Key inclusion criteria (3 listed)
- Patients with mild to moderate asthma
- Patients with mild to moderate atopic dermatitis
- Healthy individuals
Key exclusion criteria (6 listed)
- Acute or chronic infections
- Oncological diseases
- Acute systemic autoimmune diseases
- Use of systemic immunosuppressants (wait 1 month)
- Use of vitamin D supplementation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral vein punctionVitamin D level, vitamin D receptor genetic polymorphisms, allergen specific IgE and total IgE will be measured in peripheral blood | Diagnostic test | Asthma, Atopic dermatitis, Healthy individuals |
| Stool collectionGut microbiome will be investigated in stool samples. | Diagnostic test | Asthma, Atopic dermatitis, Healthy individuals |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigita Sitkauskiene, Prof. principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis and Asthma, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.