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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
Pontificia Universidad Catolica de Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, vitamin D

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Medicine, Pontificia Universidad Católica de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3 supplementation

Placebo

Arm Description

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.

Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in Th2 immunity
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
Number and phenotype of blood dendritic cells and number of regulatory T cells.
Effect of VD3 supplementation on immunity to Staphylococcus aureus
Serum cathelicidin levels, S. aureus skin carriage, and specific IgE to staphylococcal enterotoxins.
Vitamin D receptor single nucleotide polymorphisms
Effect of VDR SNPs on the VD3 response.
Change in epidermal protein expression
Gene expression of epidermal proteins by PCR obtained from lesional and non-lesional tape stripping samples.

Full Information

First Posted
November 11, 2013
Last Updated
February 28, 2015
Sponsor
Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT01996423
Brief Title
Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis
Acronym
VIDATOPIC
Official Title
Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3 supplementation
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in SCORAD index
Description
Change in Scoring Atopic Dermatitis (SCORAD) index after 6 weeks of vitamin D3 (VD3) supplementation or placebo in children with atopic dermatitis.
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Changes in Th2 immunity
Description
Eosinophil blood counts, serum IgE, Th2 lymphocytes among stimulated PBMCs, serum CCL17, CCL22, and CCL27.
Time Frame
baseline and 6 weeks
Title
Change in dendritic cell-mediated tolerance and regulatory T cells
Description
Number and phenotype of blood dendritic cells and number of regulatory T cells.
Time Frame
baseline and 6 weeks
Title
Effect of VD3 supplementation on immunity to Staphylococcus aureus
Description
Serum cathelicidin levels, S. aureus skin carriage, and specific IgE to staphylococcal enterotoxins.
Time Frame
baseline and 6 weeks
Title
Vitamin D receptor single nucleotide polymorphisms
Description
Effect of VDR SNPs on the VD3 response.
Time Frame
baseline and 6 weeks
Title
Change in epidermal protein expression
Description
Gene expression of epidermal proteins by PCR obtained from lesional and non-lesional tape stripping samples.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Number of participants with adverse events
Description
Adverse events of atopic dermatitis patients with VD3 and placebo
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Borzutzky, M.D.
Organizational Affiliation
School of Medicine, Pontificia Universidad Católica de Chile
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos A Camargo Jr., M.D., DrPH
Organizational Affiliation
Massachusetts General Hospital, Harvard University, Boston, USA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cristian Vera, M.D.
Organizational Affiliation
School of Medicine, Pontificia Universidad Católica de Chile
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lorena Cifuentes, M.D.
Organizational Affiliation
School of Medicine, Pontificia Universidad Católica de Chile
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sergio Silva, M.D.
Organizational Affiliation
School of Medicine, Pontificia Universidad Católica de Chile
Official's Role
Study Director
Facility Information:
Facility Name
School of Medicine, Pontificia Universidad Católica de Chile
City
Santiago
Country
Chile

12. IPD Sharing Statement

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Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis

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