The Association Between Human Microbiome and Vitamin D in Chronic Urticaria

China Medical University

Status: Enrolling

Conditions: Urticaria

Treatments: Other: Vitamin D; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05497596

CMUH111-REC3-066

Details and patient eligibility

About

A double-blind study to evaluate the role of human microbiome and vitamin D in the development of urticaria.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

Vitamin D (2000IU/day) for 6 months

Treatment:

Other: Vitamin D

Control group

Placebo Comparator group

Description:

placebo

Treatment:

Other: Placebo