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Analysis of Response of Subjects With Atopic Dermatitis or Psoriasis to Oral Vitamin D3

Primary Purpose

Atopic Dermatitis, Psoriasis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Vitamin D3, Atopic Dermatitis, Antimicrobial Peptide Expression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, San Diego
  • National Jewish Health
  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D3

Placebo

Arm Description

Subjects received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU]

Subjects received a 21-day course of oral vitamin D3-placebo

Outcomes

Primary Outcome Measures

Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known.
Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis.

Secondary Outcome Measures

Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.
Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.
Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis.

Full Information

First Posted
November 11, 2008
Last Updated
March 10, 2017
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Consortium of Food Allergy Research
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1. Study Identification

Unique Protocol Identification Number
NCT00789880
Brief Title
Analysis of Response of Subjects With Atopic Dermatitis or Psoriasis to Oral Vitamin D3
Official Title
Analysis of the Response of Subjects With Atopic Dermatitis to Oral Vitamin D3 by Measurement of Antimicrobial Peptide Expression in Skin and Saliva
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Consortium of Food Allergy Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed Description
Atopic Dermatitis (AD) is a chronic inflammatory skin disorder in which the skin becomes extremely itchy and is susceptible to recurrent skin infections. AD is thought to occur from a combination of immunological, genetic, and environmental factors. Individuals with AD are at risk for developing a severe and widely disseminated infection called eczema vaccinatum (EV). EV is caused when the live attenuated vaccinia virus in the vaccine reproduces and spreads throughout the body. Individuals with AD lack certain antimicrobial peptides, specifically cathelicidins. This trial also includes a sub-study with individuals who have psoriasis. Psoriasis is also an immune-mediated skin disease, and is characterized by scaling skin and inflammation (pain, swelling, heat, and redness). Most psoriasis cause patches of thick, red skin with silvery scales. These patches can itch or feel sore. This sub-study will provide additional information on psoriatic responses to oral vitamin D. (Originally listed separately as ADVN-CATH-03-01).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis, Psoriasis
Keywords
Vitamin D3, Atopic Dermatitis, Antimicrobial Peptide Expression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D3
Arm Type
Experimental
Arm Description
Subjects received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU]
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects received a 21-day course of oral vitamin D3-placebo
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Administration of oral vitamin D3 at 4000IU
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
vitamin D3 placebo
Intervention Description
Administration of oral Vitamin D3 placebo
Primary Outcome Measure Information:
Title
Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Description
Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time Frame
Baseline to Day 21
Title
Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Description
Cathelicidin (CAMP) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. Cathelicidin amount is clinically significant as it is necessary to resist infection. Cathelicidin amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time Frame
Baseline to Day 21
Title
Change From Baseline on Day 21 in Relative Abundance of CAMP mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Description
Cathelicidin (CAMP) messenger ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline, Cathelicidin abundance in psoriasis has been hypothesized to correlate with increased inflammation. No direct clinical correlation is known.
Time Frame
Baseline to Day 21
Title
Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Description
Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies as measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time Frame
Baseline to Day 21
Title
Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Oral Vitamin D3 Versus Vitamin D3-Placebo
Description
Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis, therefore the lesional skin-type was not measured in this group. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. HBD-3 amount is clinically significant as it is necessary to resist infection. HBD-3 amount is not known to be clinically relevant to the clinical signs of dermatitis associated with AD.
Time Frame
Baseline to Day 21
Title
Change From Baseline on Day 21 in Relative Abundance of HBD-3 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Description
Human Beta-defensin 3 (HBD-3) Messenger Ribonucleic acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between HBD-3 and psoriasis.
Time Frame
Baseline to Day 21
Secondary Outcome Measure Information:
Title
Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Atopic Dermatitis (AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Description
Cytokine interleukin-13 (IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.
Time Frame
Baseline to Day 21
Title
Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Non-Lesional Skin for Non-Atopic Dermatitis (Non-AD) Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Description
Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. Non-AD is defined as a healthy volunteer without atopic dermatitis. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. A decrease in IL-13 may be clinically correlated with improvement of AD.
Time Frame
Baseline to Day 21
Title
Change From Baseline on Day 21 in Relative Abundance of IL-13 mRNA in Lesional and Non-Lesional Skin for Psoriatic Participants Who Received Vitamin D3 Versus Vitamin D3-Placebo
Description
Cytokine interleukin-13 ( IL-13) Messenger Ribonucleic Acid (mRNA) expression from skin biopsies measured by quantitative real time polymerase chain reaction (qRT-PCR). Average delta cycle threshold (CT) adjusted for non-atopic average at baseline on the arithmetic scale = [(average of (CT for CAMP - CT for Glyceraldehyde-3-phosphate dehydrogenase (GAPDH)) across replicates) - (the average of (CT for CAMP - CT for GAPDH) for non-atopic subjects at baseline)]. A negative value indicates a drop from baseline and a positive value indicates an increase from baseline. There is no known clinical correlation between IL-13 and psoriasis.
Time Frame
Baseline to Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Gallo, MD, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Citations:
PubMed Identifier
16895558
Citation
Schauber J, Dorschner RA, Yamasaki K, Brouha B, Gallo RL. Control of the innate epithelial antimicrobial response is cell-type specific and dependent on relevant microenvironmental stimuli. Immunology. 2006 Aug;118(4):509-19. doi: 10.1111/j.1365-2567.2006.02399.x.
Results Reference
result
PubMed Identifier
23638978
Citation
Hata TR, Audish D, Kotol P, Coda A, Kabigting F, Miller J, Alexandrescu D, Boguniewicz M, Taylor P, Aertker L, Kesler K, Hanifin JM, Leung DY, Gallo RL. A randomized controlled double-blind investigation of the effects of vitamin D dietary supplementation in subjects with atopic dermatitis. J Eur Acad Dermatol Venereol. 2014 Jun;28(6):781-9. doi: 10.1111/jdv.12176. Epub 2013 May 3.
Results Reference
result
Links:
URL
https://www.niaid.nih.gov/
Description
National Institute of Allergy and Infectious Diseases (NIAID)
URL
https://www.niaid.nih.gov/about/dait
Description
Division of Allergy, Immunology, and Transplantation (DAIT)
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY14
Available IPD/Information Identifier
SDY14
Available IPD/Information Comments
ImmPort study identifier is SDY14.
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY14
Available IPD/Information Identifier
SDY14
Available IPD/Information Comments
ImmPort study identifier is SDY14.
Available IPD/Information Type
Study summary, -design, -assessments, -adverse events, -intervention(s), -study files et al.
Available IPD/Information URL
http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY14
Available IPD/Information Identifier
SDY14
Available IPD/Information Comments
ImmPort study identifier is SDY14.

Learn more about this trial

Analysis of Response of Subjects With Atopic Dermatitis or Psoriasis to Oral Vitamin D3

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