Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: Vitamin D3
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 supplementation<br>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. | Dietary Supplement: Vitamin D3<br> <br> * Other names: Cholecalciferol;|
| Placebo Comparator: Placebo<br>Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Th2 immunity | Eosinophil blood counts, serum IgE, Th2 lymphocytes among stimulated PBMCs, serum CCL17, CCL22, and CCL27. | baseline and 6 weeks | 
| 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 | 
| 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 | 
| Vitamin D receptor single nucleotide polymorphisms | Effect of VDR SNPs on the VD3 response. | baseline and 6 weeks | 
| Change in epidermal protein expression | Gene expression of epidermal proteins by PCR obtained from lesional and non-lesional tape stripping samples. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, vitamin D