Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis

Atopic Dermatitis Clinical Trial

— VIDATOPIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01996423
• Other study ID #: 12-185
• Secondary ID: 1130615
• Status: Completed
• Phase: N/A
• First received: November 11, 2013
• Last updated: February 28, 2015
• Start date: April 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Dietary Supplement:
• Vitamin D3

• Placebo

Locations

Country	Name	City	State
Chile	School of Medicine, Pontificia Universidad Católica de Chile	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events	Adverse events of atopic dermatitis patients with VD3 and placebo	6 weeks	Yes
Primary	Change in SCORAD index	Change in Scoring Atopic Dermatitis (SCORAD) index after 6 weeks of vitamin D3 (VD3) supplementation or placebo in children with atopic dermatitis.	baseline and 6 weeks	No
Secondary	Changes in Th2 immunity	Eosinophil blood counts, serum IgE, Th2 lymphocytes among stimulated PBMCs, serum CCL17, CCL22, and CCL27.	baseline and 6 weeks	No
Secondary	Change in dendritic cell-mediated tolerance and regulatory T cells	Number and phenotype of blood dendritic cells and number of regulatory T cells.	baseline and 6 weeks	No
Secondary	Effect of VD3 supplementation on immunity to Staphylococcus aureus	Serum cathelicidin levels, S. aureus skin carriage, and specific IgE to staphylococcal enterotoxins.	baseline and 6 weeks	No
Secondary	Vitamin D receptor single nucleotide polymorphisms	Effect of VDR SNPs on the VD3 response.	baseline and 6 weeks	No
Secondary	Change in epidermal protein expression	Gene expression of epidermal proteins by PCR obtained from lesional and non-lesional tape stripping samples.	6 weeks	No