Vitamin D treatment for children with atopic dermatitis

Vitamin D Treatment Effect for Atopic Dermatitis in Children

This study is testing if giving vitamin D to children with moderate to severe eczema can help improve their skin condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 1 Year to 18 Years
• Sex: All
• Sponsor: China Medical University Hospital (Academic / other)
• Locations: 1 site (Taichung)
• Trial ID: NCT05523986 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of vitamin D supplementation on children with moderate to severe atopic dermatitis, a chronic inflammatory skin condition. It involves a double-blind, randomized approach where participants will receive either vitamin D or a placebo for six months. The study also examines the role of the human microbiome in relation to atopic dermatitis by collecting various biological samples. The goal is to better understand the potential benefits of vitamin D in managing this condition.

Who should consider this trial

Good fit: Ideal candidates include children aged 1-18 years with moderate to severe atopic dermatitis as defined by specific clinical criteria.

Not a fit: Patients with mild atopic dermatitis or those outside the age range of 1-18 years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for children suffering from atopic dermatitis.

How similar studies have performed: Previous studies have shown positive outcomes with vitamin D supplementation in atopic dermatitis, but this specific approach is still being explored.

Eligibility criteria

Inclusion Criteria:

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:

1. skin itching
2. 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)
3. chronic persistent or recurrent dermatitis for more than 6 months.
4. 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).

Exclusion Criteria:

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

Where this trial is running

Taichung

• China Medical University Hospital — Taichung, Taiwan (Recruiting)

Study contacts

• Study coordinator: Jiu-Yao Wang, MD

Conditions Atopic Dermatitis; atopic dermatitis; human microbiome; vitamin D; vitamin D receptors and vitamin D binding protein