The Association Between Human Microbiome and Vitamin D in Chronic Urticaria

NCT ID: NCT05497596

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2025-03-31

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.

Conditions

Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment group

Vitamin D (2000IU/day) for 6 months

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: OTHER

Vitamin D (2000IU/day) for 6 months

Control group

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

Vitamin D

Vitamin D (2000IU/day) for 6 months

Intervention Type: OTHER

Placebo

Placebo

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

China Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jiu-Yao Wang, MD

Role: CONTACT

aim.cmuh@gmail.com

886422052121 ext. 4131

Facility Contacts

Jiu-Yao Wang, MD

Role: primary

aim.cmuh@gmail.com

886422052121 ext. 4131

Other Identifiers

CMUH111-REC3-066

Identifier Type: -

Identifier Source: org_study_id