Vitamin D Deficiency and Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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Treatment Of Vitamin D Deficiency And Effect On Atopic Dermatitis Severity

Conditions
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Atopic Dermatitis, Vitamin D Deficiency

Intervention / Treatment
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* Drug: Vitamin D


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard dose vitamin D<br>Treatment with cholecalciferol 400 IU daily at home. | Drug: Vitamin D<br>* Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks<br>|
| Active Comparator: High dose vitamin D<br>Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. | Drug: Vitamin D<br>* Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atopic Dermatitis Severity at the Completion of Treatment | 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). | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Restart Topical Steroids | The time to restart topical steroids. | 6 weeks |