Analysis of Response of Subjects With Atopic Dermatitis or Psoriasis to Oral Vitamin D3
Condition: Atopic Dermatitis; Psoriasis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Intervention: Vitamin D3; Placebo
Intervention description: Administration of oral vitamin D3 at 4000IU; Administration of oral Vitamin D3 placebo
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vitamin D3; Atopic Dermatitis; Antimicrobial Peptide Expression

Summary:

      This study will examine whether administration of oral Vitamin D3 given over 21 days will
      change the antimicrobial peptide expression in the skin or saliva of subjects with Atopic
      Dermatitis (AD). This study will help researchers determine if the lack of the expression of
      antimicrobial peptides in individuals with AD plays a role in the susceptibility to eczema
      vaccinatum (EV).
    

Eligibility criteria:

        Inclusion Criteria (Main Study):

          -  Definitive diagnosis of AD for at least 6 months, stringently diagnosed using the ADVN
             Standard Diagnostic Criteria, and has lesional skin present OR is a non-atopic healthy
             control subject with no personal or family history of food allergy, AD, asthma, or
             allergic rhinitis

          -  Residing in the US.

        Inclusion Criteria (Sub-Study):

          -  Definitive diagnosis of typical plaque psoriasis for at least 6 months, stringently
             diagnosed using the ADVN Standard Diagnostic Criteria; or is an AD or non-atopic
             healthy control subject participating in the main protocol ADVN CATH 03.

          -  Residing in the US.

        Exclusion Criteria (Main Study):

          -  Presence of atopy without stringent AD features, allowing only a presumptive diagnosis
             of AD

          -  Presence of AD with exfoliative erythroderma

          -  Presence of psoriasis

          -  Pregnant or lactating females

          -  Existence of ongoing dental disease (e.g., gingivitis)

          -  History of bleeding disorders

          -  Presence of severe AD that would be exacerbated by withholding of topical
             corticosteroids, oral or topical antibiotics, topical or systemic antihistamines, oral
             antivirals, immune enhancers (e.g., imiquimod), or topical calcineurin inhibitors
             within 7 days of Study Visit 2 (Baseline) and throughout the course of the trial

          -  Receiving systemic immunosuppressives, chemotherapeutic agents, anti-inflammatory
             biologics (e.g., alefacept, etanercept), systemic, oral, injectable or inhaled
             steroids, vitamin D supplements (more than 400 IU daily) or oral calcineurin
             inhibitors 30 days prior to the Study Visit 2 (Baseline) or anytime during the course
             of the trial

          -  Using topical corticosteroids, oral or topical antibiotics, oral antivirals, immune
             enhancers (e.g., imiquimod), topical or systemic antihistamines, or topical
             calcineurin inhibitors within 7 days of Study Visit 2 (Baseline) and during the course
             of the trial

          -  Receiving phototherapy (e.g., UVB, psoralen plus ultraviolet light A [PUVA]) within 30
             days of Study Visit 2 (Baseline) and during the course of the trial

          -  Having autoimmune or immunodeficiency disease

          -  Presence of active systemic fungal (excluding nail fungus), bacterial, or viral
             infections

          -  History of or presence of active systemic malignancy, excluding uncomplicated
             non-melanoma skin cancer

          -  Mental illness or history of drug or alcohol abuse that, in the opinion of the
             investigator, would interfere with the participant's ability to comply with study
             requirements

          -  Inability or unwillingness of a participant to give written informed consent

          -  Diabetes

          -  Certain screening laboratory values not within normal limits, which would include
             calcium, serum PTH, and serum creatinine

          -  History of kidney disease or kidney stones

          -  Currently taking barbiturates such as phenobarbital (Luminal)

          -  Currently taking carbamazine (Tegretol), digoxin, phenytoin (Dilantin) or fosphenytoin
             (cerebyx)

          -  Currently taking diuretics such as thiazide diuretics, calcium channel blockers, or
             beta-blockers

          -  Currently taking magnesium-containing antacids, mineral oil, cholestyramine
             (Questran), colestipol(Colestid), orlistat (xenical), the fat substitute Olestra, cod
             liver oil, fish oil, or omega 3 fatty acids

          -  Currently taking oral antifungals such as ketoconazole

          -  History of serious or life-threatening anaphylactic reaction to tape or adhesives

          -  Lidocaine allergy

          -  History of or active hyperparathyroidism, sarcoid, tuberculosis or lymphoma.

        Exclusion Criteria (Sub-Study):

          -  Presence of AD with exfoliative erythroderma

          -  Presence of psoriasis with exfoliative erythroderma or presence of guttate psoriasis,
             primary palmoplantar psoriasis, or pustular psoriasis

          -  Pregnant or lactating females

          -  Existence of ongoing dental disease (e.g., gingivitis)

          -  History of bleeding disorders

          -  Presence of psoriasis that would be severely exacerbated by withholding topical
             corticosteroids, oral or topical antibiotics, topical or systemic antihistamines, oral
             antivirals, immune enhancers (e.g.,imiquimod), or topical calcineurin inhibitors
             within 7 days of Study Visit 2 (Baseline) and throughout the course of the trial

          -  Receiving systemic immunosuppressives, chemotherapeutic agents, anti-inflammatory
             biologics (e.g., alefacept, etanercept), systemic, oral, injectable, or inhaled
             steroids, vitamin D supplements (more than 400 IU daily), or oral calcineurin
             inhibitors, 30 days prior to the Study Visit 2 (Baseline) or anytime during the course
             of the trial

          -  Using topical corticosteroids, oral or topical antibiotics, oral antivirals, immune
             enhancers (e.g., imiquimod), topical or systemic antihistamines, or topical
             calcineurin inhibitors within 7 days of Study Visit 2 (Baseline) and during the course
             of the trial

          -  Receiving phototherapy (e.g., UVB, psoralen plus ultraviolet light A [PUVA]) within 30
             days of Study Visit 2 (Baseline) and during the course of the trial

          -  Having autoimmune or immunodeficiency disease

          -  Presence of active systemic fungal (excluding nail fungus), bacterial, or viral
             infections

          -  History of or presence of active systemic malignancy, excluding uncomplicated
             non-melanoma skin cancer

          -  Mental illness or history of drug or alcohol abuse that, in the opinion of the
             investigator, would interfere with the participant's ability to comply with study
             requirements

          -  Inability or unwillingness of a participant to give written informed consent

          -  Diabetes

          -  Screening laboratory values not within normal limits, which would include calcium,
             serum PTH, and serum creatinine

          -  History of kidney disease or kidney stones

          -  Currently taking barbiturates such as phenobarbital (Luminal)

          -  Currently taking carbamazepine (Tegretol), digoxin, phenytoin (Dilantin) or
             fosphenytoin (cerebyx)

          -  Currently taking diuretics such as thiazide diuretics, calcium channel blockers, or
             beta-blockers

          -  Currently taking magnesium-containing antacids, mineral oil, cholestyramine
             (Questran), colestipol (Colestid), orlistat (xenical), the fat substitute Olestra, cod
             liver oil, fish oil, or omega 3 fatty acids

          -  Currently taking oral antifungals such as ketoconazole

          -  History of serious or life-threatening anaphylactic reaction to tape or adhesives

          -  Lidocaine allergy

          -  History of or active hyperparathyroidism, sarcoid, tuberculosis or lymphoma.