Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis (VIDATOPIC)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis|
- Change in SCORAD index [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]Change in Scoring Atopic Dermatitis (SCORAD) index after 6 weeks of vitamin D3 (VD3) supplementation or placebo in children with atopic dermatitis.
- Changes in Th2 immunity [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]Number and phenotype of blood dendritic cells and number of regulatory T cells.
- Effect of VD3 supplementation on immunity to Staphylococcus aureus [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]Serum cathelicidin levels, S. aureus skin carriage, and specific IgE to staphylococcal enterotoxins.
- Vitamin D receptor single nucleotide polymorphisms [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]Effect of VDR SNPs on the VD3 response.
- Change in epidermal protein expression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Gene expression of epidermal proteins by PCR obtained from lesional and non-lesional tape stripping samples.
- Number of participants with adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]Adverse events of atopic dermatitis patients with VD3 and placebo
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Vitamin D3 supplementation
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
Other Name: Cholecalciferol
Placebo Comparator: Placebo
Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks.
|Dietary Supplement: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01996423
|Contact: Arturo Borzutzky, M.D.||firstname.lastname@example.org|
|School of Medicine, Pontificia Universidad Católica de Chile||Recruiting|
|Sub-Investigator: Catalina Le Roy, M.D.|
|Sub-Investigator: Rodrigo Hoyos-Bachiloglu, M.D.|
|Sub-Investigator: Cristián Navarrete, M.D.|
|Sub-Investigator: Francisca Cristi, MSc|
|Sub-Investigator: Carolina Iturriaga, RN|
|Principal Investigator:||Arturo Borzutzky, M.D.||School of Medicine, Pontificia Universidad Católica de Chile|
|Study Director:||Carlos A Camargo Jr., M.D., DrPH||Massachusetts General Hospital, Harvard University, Boston, USA|
|Study Director:||Cristian Vera, M.D.||School of Medicine, Pontificia Universidad Católica de Chile|
|Study Director:||Lorena Cifuentes, M.D.||School of Medicine, Pontificia Universidad Católica de Chile|
|Study Director:||Sergio Silva, M.D.||School of Medicine, Pontificia Universidad Católica de Chile|