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

February 28, 2015 updated by: Pontificia Universidad Catolica de Chile

Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • School of Medicine, Pontificia Universidad Catolica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Cholecalciferol
Placebo Comparator: Placebo
Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 6 weeks
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.
baseline and 6 weeks
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.
baseline and 6 weeks
Vitamin D receptor single nucleotide polymorphisms
Time Frame: baseline and 6 weeks
Effect of VDR SNPs on the VD3 response.
baseline and 6 weeks
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.
6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events
Time Frame: 6 weeks
Adverse events of atopic dermatitis patients with VD3 and placebo
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Principal Investigator: Arturo Borzutzky, M.D., School of Medicine, Pontificia Universidad Catolica 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 Catolica de Chile
  • Study Director: Lorena Cifuentes, M.D., School of Medicine, Pontificia Universidad Catolica de Chile
  • Study Director: Sergio Silva, M.D., School of Medicine, Pontificia Universidad Catolica de Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 21, 2013

First Posted (Estimate)

November 27, 2013

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

February 28, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-185
  • 1130615 (Other Grant/Funding Number: FONDECYT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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