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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01996423
First Posted: November 27, 2013
Last Update Posted: March 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile
  Purpose
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: Quadruple (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

  Eligibility

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

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
Information from the National Library of Medicine

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


Locations
Chile
School of Medicine, Pontificia Universidad Católica de Chile
Santiago, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
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
ClinicalTrials.gov Identifier: NCT01996423     History of Changes
Other Study ID Numbers: 12-185
1130615 ( Other Grant/Funding Number: FONDECYT )
First Submitted: November 11, 2013
First Posted: November 27, 2013
Last Update Posted: March 3, 2015
Last Verified: February 2015

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents