Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1130615 | Other Grant/Funding Number | FONDECYT |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D3 supplementation | Experimental | 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 Comparator | Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement |
|
| |
| Placebo |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Adverse events of atopic dermatitis patients with VD3 and placebo | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arturo Borzutzky, M.D. | School of Medicine, Pontificia Universidad Católica de Chile | Principal Investigator |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Medicine, Pontificia Universidad Católica de Chile | Santiago | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38483248 | Derived | Borzutzky A, Iturriaga C, Perez-Mateluna G, Cristi F, Cifuentes L, Silva-Valenzuela S, Vera-Kellet C, Cabalin C, Hoyos-Bachiloglu R, Navarrete-Dechent C, Cossio ML, Le Roy C, Camargo CA Jr. Effect of weekly vitamin D supplementation on the severity of atopic dermatitis and type 2 immunity biomarkers in children: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2024 Sep;38(9):1760-1768. doi: 10.1111/jdv.19959. Epub 2024 Mar 14. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Supplement |
|
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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |