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Completed

NCT Number: NCT01996423

Impact of Vitamin D Supplementation on Severity 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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Medicine, Pontificia Universidad Católica de Chile

Santiago, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

Other names: Cholecalciferol

Placebo

Dietary Supplement

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Vitamin D receptor single nucleotide polymorphisms

    Time frame: baseline and 6 weeks

    Effect of VDR SNPs on the VD3 response.

  5. 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 outcomes

  1. Number of participants with adverse events

    Time frame: 6 weeks

    Adverse events of atopic dermatitis patients with VD3 and placebo

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

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

Acronym: VIDATOPIC

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2013
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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