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Atopic Dermatitis (AD) is a skin disorder in which people often have swelling and skin infection. People with this disease cannot receive the smallpox vaccine because it could cause them to have a fatal reaction known as eczema vaccinatum (EV). AD subjects have a lack of antimicrobial peptides (AMPs) under inflammatory conditions. This is a substudy to the ADVN Vitamin D3 study; ClinicalTrials.gov identifer NCT00789880.
The goal of the Atopic Dermatitis and Vaccinia Network (ADVN) is to research methods for preventing atopic dermatitis (AD) subjects from contracting eczema vaccinatum (EV), a potentially fatal complication of smallpox vaccinations. A critical host defense defect uncovered in subjects with AD is their apparent relative lack of expression of antimicrobial peptides (AMPs), specifically cathelicidins, under inflammatory conditions (1). AMPs are important effectors and triggers in the innate immune system, and the lack of expression of these peptides in AD patients could be a key component in their susceptibility to EV. The main Vitamin D study will examine whether or not the administration of oral Vitamin D3 over 21 days will change the AMP expression in the skin and saliva of AD subjects and healthy controls.
Many new avenues of research are also being explored in this subject population and require initial exploratory data to be collected to assess their potential. As an addition to the Antimicrobial Response to Oral Vitamin D protocol, this substudy protocol will provide further control information on psoriatic responses to oral vitamin D; information on bacterial colonization in AD, non-AD, and psoriatic subjects; and assess tape stripping as a noninvasive method for the measurement of cathelicidin skin expression.
Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Vitamin D3, Placebo
University of California, San Diego
National Institute of Allergy and Infectious Diseases (NIAID)
Published on BioPortfolio: 2014-07-24T14:07:20-0400
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