Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis (VIDATOPIC)
|ClinicalTrials.gov Identifier: NCT01996423|
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : March 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Atopic Dermatitis||Dietary Supplement: Vitamin D3 Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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
- Change in SCORAD index [ Time Frame: 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.
- Changes in Th2 immunity [ Time Frame: 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 [ Time Frame: baseline and 6 weeks ]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 ]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 ]Effect of VDR SNPs on the VD3 response.
- Change in epidermal protein expression [ Time Frame: 6 weeks ]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 ]Adverse events of atopic dermatitis patients with VD3 and placebo
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996423
|School of Medicine, Pontificia Universidad Católica de Chile|
|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|