UrticariaNCT05497596
The Association Between Human Microbiome and Vitamin D in Chronic Urticaria
A study testing Vitamin D in people with Urticaria, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
A double-blind study to evaluate the role of human microbiome and vitamin D in the development of urticaria. Read more about this study
- Who is it for?
- Ages 0 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Urticaria
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Aug 2022to 31 Mar 2025
- Phase
- Interventional
- 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 0 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Experimental group: patients with chronic spontaneous urticaria under the age of 18 .
- Control group: healthy children under the age of 18 (eg, healthy siblings of sick children).
Who cannot join
- Recruit patients who have used antibiotics, systemic steroids, and immunosuppressants in the previous month.
- Patients with C1 esterase inhibitor deficiency, lymphocytopenia, thrombocytopenia, severe diseases involving heart, liver, or kidney, metabolic disease, or autoimmune disease.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Jiu-Yao Wang, MD, 886422052121 ext. 4131, aim.cmuh@gmail.com
About this study
A double-blind study to evaluate the role of human microbiome and vitamin D in the development of urticaria.
Read the detailed description
Urticaria is a chronic allergic inflammatory disorder. Genetic and environmental factors, such as exposure to allergens and microbes, have a detrimental role in the development of chronic urticaria. Vitamin D also has an important role in urticaria. Lower sera vitamin D level was observed in patients that developed urticaria. Vitamin D binding protein (DBP) bound to vitamin D and regulated its metabolites in the circulation. Moreover, vitamin D receptors (VDR) have been identified on nearly all cells of the immune system. It may contribute to maintenance of intestinal barrier function by preventing increased intestinal permeability, dysbiosis, inflammation, and a lack of immune tolerance in the gut.
The investigators plan to design a double-blind trial to evaluate the role of human microbiome and vitamin D in the development of urticaria. We will enroll children with chronic urticaria (CU) and age and gender matched healthy children,and collected their venous blood and microbiome samples of nasal and anal swab. Then, CU subjects will be given vitamin D or placebo for 6 months in a randomized, double-blind way. After six months of follow-up, their blood, nasal cavity, and intestinal bacterial samples were taken. All microbial analysis, allergen detection, vitamin D concentration, VDR, DBP genotype will be analyzed by the core laboratory and bioinformatics center of CMUH.
The investigators believe this study can answer the cause-effect relationships of microbiota and vitamin D in the development of CU, and design a microbiota-related preventive and treatment strategy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DOther
Vitamin D (2000IU/day) for 6 months
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Vitamin D (2000IU/day) for 6 months Receives: Other: Vitamin D |
| Control group | Placebo comparator | placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of vitamin D
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Measured: Month 0
Levels of vitamin D
Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.
Measured: Month 6
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein.
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Measured: Month 0
Microbiome Microbiome
Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
Measured: Month 0
Microbiome Microbiome
Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing,and to follow the change from baseline in microbiome at month 6.
Measured: Month 6
Total IgE
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.
Measured: Month 0
Total IgE
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to follow the change from baseline in total IgE at month 6.
Measured: Month 6
Allergen-specific IgE
Plasma allergen-specific IgE will be measured by BioIC ®.
Measured: Month 0
Secondary outcomes (2)
Quality of Life Assessment
Patients will rate their CU symptoms and the impact of their CU on various aspects of their lives. Each question is scored from 0 (not at all) to 3 (very much). Overall score, on scale of 0 to 57.
Measured: Month 0 to Month 6
The Urticaria Activity Score 7 (UAS7)
The Urticaria Activity Score 7 measures number the weekly average of hives and pruritus measured twice a day. It scores from 0 to 42.
Measured: Month 0 to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start2 Aug 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497596
- Sponsor's protocol ID
- CMUH111-REC3-066
- Status last verified
- Sep 2023
- First submitted
- 11 Jul 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Human Microbiome and Vitamin D in Chronic Urticaria
- ClinicalTrials.gov ID
- NCT05497596
- Acronym / sponsor ID
- CMUH111-REC3-066
- Conditions
- Urticaria
- Keywords
- Vitamin D, human microbiome, vitamin D receptors and vitamin D binding protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 2 Aug 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 11 Aug 2022 (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.
A double-blind study to evaluate the role of human microbiome and vitamin D in the development of urticaria.
Detailed description
Urticaria is a chronic allergic inflammatory disorder. Genetic and environmental factors, such as exposure to allergens and microbes, have a detrimental role in the development of chronic urticaria. Vitamin D also has an important role in urticaria. Lower sera vitamin D level was observed in patients that developed urticaria. Vitamin D binding protein (DBP) bound to vitamin D and regulated its metabolites in the circulation. Moreover, vitamin D receptors (VDR) have been identified on nearly all cells of the immune system. It may contribute to maintenance of intestinal barrier function by preventing increased intestinal permeability, dysbiosis, inflammation, and a lack of immune tolerance in the gut.
The investigators plan to design a double-blind trial to evaluate the role of human microbiome and vitamin D in the development of urticaria. We will enroll children with chronic urticaria (CU) and age and gender matched healthy children,and collected their venous blood and microbiome samples of nasal and anal swab. Then, CU subjects will be given vitamin D or placebo for 6 months in a randomized, double-blind way. After six months of follow-up, their blood, nasal cavity, and intestinal bacterial samples were taken. All microbial analysis, allergen detection, vitamin D concentration, VDR, DBP genotype will be analyzed by the core laboratory and bioinformatics center of CMUH.
The investigators believe this study can answer the cause-effect relationships of microbiota and vitamin D in the development of CU, and design a microbiota-related preventive and treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Vitamin DVitamin D (2000IU/day) for 6 months |
| Control group | Placebo comparator | Other: Placeboplacebo |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Experimental group: patients with chronic spontaneous urticaria under the age of 18 .
- Control group: healthy children under the age of 18 (eg, healthy siblings of sick children).
Key exclusion criteria (2 listed)
- Recruit patients who have used antibiotics, systemic steroids, and immunosuppressants in the previous month.
- Patients with C1 esterase inhibitor deficiency, lymphocytopenia, thrombocytopenia, severe diseases involving heart, liver, or kidney, metabolic disease, or autoimmune disease.
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 |
|---|---|---|
| Vitamin DVitamin D (2000IU/day) for 6 months | Other | Treatment group |
| PlaceboPlacebo | Other | Control group |
Primary outcome
Levels of vitamin D
Time frame: Month 0
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Levels of vitamin D
Time frame: Month 6
Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein.
Time frame: Month 0
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Microbiome Microbiome
Time frame: Month 0
Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
Microbiome Microbiome
Time frame: Month 6
Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing,and to follow the change from baseline in microbiome at month 6.
Total IgE
Time frame: Month 0
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.
Total IgE
Time frame: Month 6
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to follow the change from baseline in total IgE at month 6.
Allergen-specific IgE
Time frame: Month 0
Plasma allergen-specific IgE will be measured by BioIC ®.
2 secondary outcomes
Quality of Life Assessment
Time frame: Month 0 to Month 6
The Urticaria Activity Score 7 (UAS7)
Time frame: Month 0 to Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Urticaria, run by China Medical University Hospital at 1 site in Taiwan.
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 2 inclusion and 2 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 7 Sep 2023. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Contact Jiu-Yao Wang, MD (886422052121 ext. 4131, aim.cmuh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of vitamin D (time frame: Month 0). The study lists 8 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 7 Sep 2023.