Atopic DermatitisPhase 2NCT00789880
Analysis of Response of Subjects With Atopic Dermatitis or Psoriasis to Oral Vitamin D3
A Phase 2 study testing Vitamin D3 in people with Atopic Dermatitis and Psoriasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Psoriasis
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 51Show fewer
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
National Jewish Health
Denver, Colorado, 80206
Oregon Health & Science University
Portland, Oregon, 97239
University of California, San Diego
San Diego, California, 92037
About this study
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
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).
Read the 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).
- Conditions
- Atopic Dermatitis, Psoriasis
- Being tested
- Vitamin D3, Placebo
- Keywords
- Vitamin D3, Atopic Dermatitis, Antimicrobial Peptide Expression
- Medical subject headings
- Dermatitis, Atopic, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called cholecalciferol
Administration of oral vitamin D3 at 4000IU
PlaceboDrug
Also called vitamin D3 placebo
Administration of oral Vitamin D3 placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Subjects received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] Receives: Drug: Vitamin D3 |
| Placebo | Placebo comparator | Subjects received a 21-day course of oral vitamin D3-placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 21
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.
Measured: Baseline to Day 21
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.
Measured: Baseline to Day 21
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.
Measured: Baseline to Day 21
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.
Measured: Baseline to Day 21
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.
Measured: Baseline to Day 21
Secondary outcomes (3)
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.
Measured: Baseline to Day 21
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.
Measured: Baseline to Day 21
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.
Measured: Baseline to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Consortium of Food Allergy Research
- Responsible party
- Sponsor
- Investigators
- Richard Gallo, MD, PhD, Study chair, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789880
- Sponsor's protocol ID
- DAIT ADVN CATH 03
- Other IDs
- DAIT-ADVN-CATH-03-01 Sub-study
- Status last verified
- Mar 2017
- First submitted
- 11 Nov 2008
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 16895558Hata 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.
PubMed 23638978
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00789880
- Acronym / sponsor ID
- DAIT ADVN CATH 03
- Conditions
- Atopic Dermatitis, Psoriasis
- Keywords
- Vitamin D3, Atopic Dermatitis, Antimicrobial Peptide Expression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Consortium of Food Allergy Research
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Posted 22 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Drug: Vitamin D3Subjects received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units [IU] |
| Placebo | Placebo comparator | Drug: PlaceboSubjects received a 21-day course of oral vitamin D3-placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (51 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Also: cholecalciferolAdministration of oral vitamin D3 at 4000IU | Drug | Vitamin D3 |
| PlaceboAlso: vitamin D3 placeboAdministration of oral Vitamin D3 placebo | Drug | Placebo |
Primary outcome
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
Time frame: Baseline to Day 21
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
Time frame: Baseline to Day 21
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
Time frame: Baseline to Day 21
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
Time frame: Baseline to Day 21
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
Time frame: Baseline to Day 21
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
Time frame: Baseline to Day 21
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.
3 secondary outcomes
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
Time frame: Baseline to Day 21
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
Time frame: Baseline to Day 21
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
Time frame: Baseline to Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16895558Schauber 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 publication: PubMed 23638978Hata 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.
- National Institute of Allergy and Infectious Diseases (NIAID)Link provided by the sponsor.
- Division of Allergy, Immunology, and Transplantation (DAIT)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Gallo, MD, PhD study chair
University of California, San Diego
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 in people with Atopic Dermatitis and Psoriasis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline to Day 21). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00789880, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.