Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis

Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01996423

Acronym

VIDATOPIC

Enrollment

101

Registered

2013-11-27

Start date

2014-04-30

Completion date

2014-12-31

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, vitamin D

Brief summary

The purpose of this study is to determine whether oral vitamin D supplementation improves the clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate the effects of vitamin D supplementation on several key aspects of the immune system of children with atopic dermatitis.

Interventions

DIETARY_SUPPLEMENTVitamin D3

DIETARY_SUPPLEMENTPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 17 Years

Healthy volunteers

Inclusion criteria

* Atopic dermatitis diagnosed according to Hanifin and Rajka criteria * Age 2 - 17 years * SCORAD 10 - 103

Exclusion criteria

* Active skin infection * History of underlying illness causing immunosuppression within the past 2 years * Immunosuppressors taken within the past month * Parathyroid disease * Sarcoidosis * Acute or chronic renal disease * Hyper or hypocalcemia * Thyroid disease * Osteomalacia or Paget's disease of bone * Malabsorption * Use of VD supplements (\> 400 IU daily) or fish oil supplements in the past month * Treatment for known VD deficiency in the last 6 months * Treatment with moderate or high potency topical corticosteroids, oral or topical antibiotics, oral antivirals, immune enhancers, or topical calcineurin inhibitors in the past 7 days * Phototherapy in the past month * Autoimmune disease or immunodeficiency * Planned trip to sunny climate during the 6-week study.

Design outcomes

Primary

Measure	Time frame	Description
Change in SCORAD index	baseline and 6 weeks	Change in Scoring Atopic Dermatitis (SCORAD) index after 6 weeks of vitamin D3 (VD3) supplementation or placebo in children with atopic dermatitis.

Secondary

Measure	Time frame	Description
Changes in Th2 immunity	baseline and 6 weeks	Eosinophil blood counts, serum IgE, Th2 lymphocytes among stimulated PBMCs, serum CCL17, CCL22, and CCL27.
Change in dendritic cell-mediated tolerance and regulatory T cells	baseline and 6 weeks	Number and phenotype of blood dendritic cells and number of regulatory T cells.
Vitamin D receptor single nucleotide polymorphisms	baseline and 6 weeks	Effect of VDR SNPs on the VD3 response.
Change in epidermal protein expression	6 weeks	Gene expression of epidermal proteins by PCR obtained from lesional and non-lesional tape stripping samples.
Effect of VD3 supplementation on immunity to Staphylococcus aureus	baseline and 6 weeks	Serum cathelicidin levels, S. aureus skin carriage, and specific IgE to staphylococcal enterotoxins.

Other

Measure	Time frame	Description
Number of participants with adverse events	6 weeks	Adverse events of atopic dermatitis patients with VD3 and placebo

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026