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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Pontificia Universidad Catolica de Chile
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01996423
First received: November 11, 2013
Last updated: May 1, 2014
Last verified: May 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Effect of VDR SNPs on the VD3 response.

  • Change in epidermal protein expression [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Adverse events of atopic dermatitis patients with VD3 and placebo


Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: March 2016
Estimated 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

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01996423

Contacts
Contact: Arturo Borzutzky, M.D. 56-2-23543753 arturobor@med.puc.cl

Locations
Chile
School of Medicine, Pontificia Universidad Católica de Chile Recruiting
Santiago, Chile
Sub-Investigator: Catalina Le Roy, M.D.         
Sub-Investigator: Rodrigo Hoyos-Bachiloglu, M.D.         
Sub-Investigator: Cristián Navarrete, M.D.         
Sub-Investigator: Francisca Cristi, MSc         
Sub-Investigator: Carolina Iturriaga, RN         
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

No publications provided

Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01996423     History of Changes
Other Study ID Numbers: 12-185, 1130615
Study First Received: November 11, 2013
Last Updated: May 1, 2014
Health Authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica

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

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

ClinicalTrials.gov processed this record on August 19, 2014