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

NCT ID: NCT00789880

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-12-31

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).

Conditions

Atopic Dermatitis; Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin D3

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

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

Administration of oral vitamin D3 at 4000IU

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administration of oral Vitamin D3 placebo

Interventions

Vitamin D3

Administration of oral vitamin D3 at 4000IU

Intervention Type: DRUG

Placebo

Administration of oral Vitamin D3 placebo

Intervention Type: DRUG

Other Intervention Names

cholecalciferol; vitamin D3 placebo

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Consortium of Food Allergy Research

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Gallo, MD, PhD

Role: STUDY_CHAIR

University of California, San Diego

Locations

University of California, San Diego

San Diego, California, United States

National Jewish Health

Denver, Colorado, United States

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16895558 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23638978 (View on PubMed)

Related Links

https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID)

https://www.niaid.nih.gov/about/dait

Division of Allergy, Immunology, and Transplantation (DAIT)

Other Identifiers

DAIT-ADVN-CATH-03-01 Sub-study

Identifier Type: OTHER

Identifier Source: secondary_id

DAIT ADVN CATH 03

Identifier Type: -

Identifier Source: org_study_id

NCT01078259

Identifier Type: -

Identifier Source: nct_alias