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Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis (VIDATOPIC)

This study has been completed.
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile Identifier:
First received: November 11, 2013
Last updated: February 28, 2015
Last verified: February 2015
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.

Condition Intervention
Atopic Dermatitis
Dietary Supplement: Vitamin D3
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis

Resource links provided by NLM:

Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Other Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 6 weeks ]
    Adverse events of atopic dermatitis patients with VD3 and placebo

Enrollment: 101
Study Start Date: April 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01996423

School of Medicine, Pontificia Universidad Católica de Chile
Santiago, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica 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
  More Information

Responsible Party: Pontificia Universidad Catolica de Chile Identifier: NCT01996423     History of Changes
Other Study ID Numbers: 12-185
1130615 ( Other Grant/Funding Number: FONDECYT )
Study First Received: November 11, 2013
Last Updated: February 28, 2015

Keywords provided by Pontificia Universidad Catolica de Chile:
Atopic dermatitis
vitamin D

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 28, 2017