Vitamin D Treatment Effect for Atopic Dermatitis in Children

NCT05523986 | Unknown

• 1 other identifier: CMUH111-REC1-111
• Study Type: interventional
• Target: 300
• 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 atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; human microbiome; vitamin D; 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, skin 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, skin 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)

• The Eczema Area and Severity Index (EASI)

  Month 0 to Month 6

• Patient Oriented Eczema Measure (POEM)

  Month 0 to Month 6

Study Arms (2)

Experimental: Treatment group

EXPERIMENTAL

Vitamin D (2000IU/day) for 6 months

Other: Vitamin D

Placebo Comparator: Control group

PLACEBO COMPARATOR

placebo

Other: Placebo

Interventions

Vitamin D OTHER

Vitamin D (2000IU/day) for 6 months

Experimental: Treatment group

Placebo OTHER

Placebo

Placebo Comparator: Control group

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Experimental group: Patients were 1-18 years old with EASI score moderate to severe atopic dermatitis, and atopic dermatitis was defined as three or more of the following statements to be diagnosed as atopic dermatitis:
• skin itching
• typical skin symptoms (including eczematous dermatitis or lichenified dermatitis) and location (mostly on the extensor side of the face and body in infants and young children, and on the flexor side of joints in adults)
• chronic persistent or recurrent dermatitis for more than 6 months.
• Individuals or family members with atopic constitution such as allergic rhinitis, asthma, atopic dermatitis or urticaria.
• Control group:healthy children under the age of 18 (eg, healthy siblings of sick children).

You may not qualify if:

• Less than 1 year old or more than 18 years old.
• Patients with mild EASI severity of atopic dermatitis.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; 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: August 29, 2022
• First Posted: September 1, 2022
• Study Start: August 9, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

TW (1)