Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis (VIDATOPIC)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|