The Association Between Human Microbiome and Vitamin D in Chronic Urticaria

NCT05497596 | Unknown

• 1 other identifier: CMUH111-REC3-066
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urticaria

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Levels of vitamin D

  Vitamin D will be measured in a blood sample by ELISA to determine baseline status.

  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.

  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.

  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.

  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.

  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.

  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.

  Month 6

• Allergen-specific IgE

  Plasma allergen-specific IgE will be measured by BioIC ®.

  Month 0

Secondary Outcomes (2)

• Quality of Life Assessment

  Month 0 to Month 6

• The Urticaria Activity Score 7 (UAS7)

  Month 0 to Month 6

Study Arms (2)

Treatment group

EXPERIMENTAL

Vitamin D (2000IU/day) for 6 months

Other: Vitamin D

Control group

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

Vitamin D OTHER

Vitamin D (2000IU/day) for 6 months

Treatment group

Placebo OTHER

Placebo

Control group

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Urticaria

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Jiu-Yao Wang, MD

CONTACT

886422052121; aim.cmuh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: August 11, 2022
• Study Start: August 2, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

TW (1)