Vitamin D Deficiency and Atopic Dermatitis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-04-30

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.

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Detailed Description

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Conditions

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Atopic Dermatitis Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Standard dose vitamin D

Treatment with cholecalciferol 400 IU daily at home.

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks

High dose vitamin D

Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks

Interventions

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Vitamin D

Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks

Intervention Type DRUG

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)

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No