Vitamin D Deficiency and Atopic Dermatitis

Not Applicable

Terminated

• Conditions: Atopic Dermatitis; Vitamin D Deficiency
• Interventions: Drug: Vitamin D

• Registration Number: NCT01337635
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2011-04-18
• Study First Posted: 2011-04-19
• Primary Completion: 2012-12
• Study Completion: 2013-04
• Results First Submitted: 2014-09-16
• Results First Submitted QC: 2015-04-06
• Results First Posted: 2015-04-08
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-07
• Last Update Posted: 2018-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard dose vitamin D	Vitamin D	Treatment with cholecalciferol 400 IU daily at home.
High dose vitamin D	Vitamin D	Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.

Primary Outcome Measures

Name	Time	Method
Atopic Dermatitis Severity at the Completion of Treatment	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

Name	Time	Method
Time to Restart Topical Steroids	6 weeks	The time to restart topical steroids.

Trial Locations

Locations (1)

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States