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NCT01337635 Clinical Trial

Vitamin D Deficiency and Atopic Dermatitis

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01337635
Other study ID # CHW 10/146, GC 1169
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 2010
Est. completion date April 2013

Study information
Verified date November 2018
Source Medical College of Wisconsin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 7
Est. completion date April 2013
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin D
Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks

Locations
Country Name City State
United States Children's Hospital of Wisconsin Milwaukee Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
Medical College of Wisconsin Children's Hospital and Health System Foundation, Wisconsin

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Time to Restart Topical Steroids The time to restart topical steroids. 6 weeks
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