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The Association Between Human Microbiome and Vitamin D in Chronic Urticaria

The Association Between Human Microbiome and Vitamin D in Chronic Urticaria

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05497596
Enrollment
150
Registered
2022-08-11
Start date
2022-08-02
Completion date
2025-03-31
Last updated
2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urticaria

Keywords

Vitamin D, human microbiome, vitamin D receptors and vitamin D binding protein

Brief summary

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.

Interventions

OTHERVitamin D

Vitamin D (2000IU/day) for 6 months

OTHERPlacebo

Placebo

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

1. Experimental group: patients with chronic spontaneous urticaria under the age of 18 . 2. Control group: healthy children under the age of 18 (eg, healthy siblings of sick children).

Exclusion criteria

1. Recruit patients who have used antibiotics, systemic steroids, and immunosuppressants in the previous month. 2. Patients with C1 esterase inhibitor deficiency, lymphocytopenia, thrombocytopenia, severe diseases involving heart, liver, or kidney, metabolic disease, or autoimmune disease.

Design outcomes

Primary

MeasureTime frameDescription
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein.Month 0Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Total IgEMonth 0Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.
Allergen-specific IgEMonth 0Plasma allergen-specific IgE will be measured by BioIC ®.
Levels of vitamin DMonth 0Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Microbiome MicrobiomeMonth 0Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.

Secondary

MeasureTime frameDescription
The Urticaria Activity Score 7 (UAS7)Month 0 to Month 6The Urticaria Activity Score 7 measures number the weekly average of hives and pruritus measured twice a day. It scores from 0 to 42.
Quality of Life AssessmentMonth 0 to Month 6Patients 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.

Countries

Taiwan

Contacts

Primary ContactJiu-Yao Wang, MD
aim.cmuh@gmail.com886422052121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026