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Vitamin D Deficiency and Atopic Dermatitis

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. Identifier: NCT01337635
Recruitment Status : Terminated (Not meeting enrollment goals.)
First Posted : April 19, 2011
Results First Posted : April 8, 2015
Last Update Posted : December 5, 2018
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Yvonne Chiu, Medical College of Wisconsin

Brief Summary:
Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier, inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble vitamin that is primarily acquired through local production in the skin after ultraviolet light exposure but can also be obtained through natural and supplemental dietary sources. This randomized controlled trial will examine the effects of vitamin D repletion on atopic dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will have improved cutaneous disease after treatment with high dose as compared to standard dose vitamin D.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Vitamin D Deficiency Drug: Vitamin D Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Treatment Of Vitamin D Deficiency And Effect On Atopic Dermatitis Severity
Study Start Date : November 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: Standard dose vitamin D
Treatment with cholecalciferol 400 IU daily at home.
Drug: Vitamin D
Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks

Active Comparator: High dose vitamin D
Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.
Drug: Vitamin D
Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks

Primary Outcome Measures :
  1. Atopic Dermatitis Severity at the Completion of Treatment [ Time Frame: 6 weeks ]
    SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome).

Secondary Outcome Measures :
  1. Time to Restart Topical Steroids [ Time Frame: 6 weeks ]
    The time to restart topical steroids.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Serum 25-hydroxyvitamin D level <20 ng/ml (<50 nmol/L)
  • Diagnosed with atopic dermatitis by a CHW pediatric dermatologist
  • Age 1-18 years old
  • Primary residence in Milwaukee County
  • Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis [SCORAD] score greater than 15)
  • On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)

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 identifier (NCT number): NCT01337635

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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
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Principal Investigator: Yvonne Chiu, MD Children's Hospital and Health System Foundation, Wisconsin
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Responsible Party: Yvonne Chiu, Assistant Professor, Medical College of Wisconsin Identifier: NCT01337635    
Other Study ID Numbers: CHW 10/146, GC 1169
First Posted: April 19, 2011    Key Record Dates
Results First Posted: April 8, 2015
Last Update Posted: December 5, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Dermatitis, Atopic
Vitamin D Deficiency
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents