Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: Vitamin D3; Dietary Supplement: Placebo

• Registration Number: NCT01996423
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Study Start: 2014-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-28
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D3 supplementation	Vitamin D3	Subjects in the experimental arm will receive weekly vitamin D3 doses in oral suspension during 6 weeks. Weekly dose varies according to age group: VD3 8000 IU between ages 2-5.9 years, VD3 12000 IU between ages 6-11.9 years, VD3 16000 IU between ages 12-17.9 years.
Placebo	Placebo	Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Changes in Th2 immunity	baseline and 6 weeks	Eosinophil blood counts, serum IgE, Th2 lymphocytes among stimulated PBMCs, serum CCL17, CCL22, and CCL27.
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.

Trial Locations

Locations (1)

School of Medicine, Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, Chile