Trial Outcomes & Findings for Analysis of Response of Subjects With Atopic Dermatitis or Psoriasis to Oral Vitamin D3 (NCT NCT00789880)

Last Updated: 2017-04-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

Baseline to Day 21

Results posted on

2017-04-12

Participant Flow

From January 2009 to November 2009, three centers in the United States recruited participants 18 to 70 years of age who fulfilled eligibility criteria. Refer to the Eligibility section for more details.

Participant milestones

Participant milestones
Measure	Vitamin D (Non-AD) Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units \[IU\] daily).	Vitamin D (AD) Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Vitamin D (Psoriasis) Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (Non-AD) Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.	Placebo (AD) Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.	Placebo (Psoriasis) Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.
Overall Study STARTED	16	16	8	16	18	8
Overall Study COMPLETED	15	15	8	15	15	8
Overall Study NOT COMPLETED	1	1	0	1	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Vitamin D (Non-AD) Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units \[IU\] daily).	Vitamin D (AD) Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (Non-AD) Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.	Placebo (AD) Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
Overall Study Adverse Event	0	0	0	1
Overall Study Protocol Violation	0	1	1	0
Overall Study Withdrawal by Subject	1	0	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D (Non-AD) n=16 Participants Healthy Volunteer participants who did not have atopic dermatitis (Non-AD) and received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 international units \[IU\] daily).	Vitamin D (AD) n=16 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Vitamin D (Psoriasis) n=8 Participants Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (Non-AD) n=16 Participants Healthy Volunteer participants who did not have AD (Non-AD) and received a 21-day course of oral vitamin D3-placebo.	Placebo (AD) n=18 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.	Placebo (Psoriasis) n=8 Participants Participants classified as psoriasis as defined by the ADVN Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3-placebo.	Total n=82 Participants Total of all reporting groups
Serum Vitamin D 25-Hydroxy (ng/mL)	28.8 ng/mL STANDARD_DEVIATION 13.9 • n=93 Participants	27.9 ng/mL STANDARD_DEVIATION 9.7 • n=4 Participants	31.3 ng/mL STANDARD_DEVIATION 8.5 • n=27 Participants	30.4 ng/mL STANDARD_DEVIATION 11.2 • n=483 Participants	29.3 ng/mL STANDARD_DEVIATION 12.2 • n=36 Participants	28.3 ng/mL STANDARD_DEVIATION 10.7 • n=10 Participants	29.2 ng/mL STANDARD_DEVIATION 11.2 • n=115 Participants
Serum Creatinine (mg/dL)	0.8 mg/dL STANDARD_DEVIATION 0.1 • n=93 Participants	0.8 mg/dL STANDARD_DEVIATION 0.1 • n=4 Participants	0.8 mg/dL STANDARD_DEVIATION 0.2 • n=27 Participants	0.8 mg/dL STANDARD_DEVIATION 0.2 • n=483 Participants	0.8 mg/dL STANDARD_DEVIATION 0.2 • n=36 Participants	0.8 mg/dL STANDARD_DEVIATION 0.1 • n=10 Participants	0.8 mg/dL STANDARD_DEVIATION 0.2 • n=115 Participants
Age, Continuous	31.4 years STANDARD_DEVIATION 12.3 • n=93 Participants	32.2 years STANDARD_DEVIATION 10.5 • n=4 Participants	40.5 years STANDARD_DEVIATION 11.6 • n=27 Participants	32.2 years STANDARD_DEVIATION 8.9 • n=483 Participants	28.6 years STANDARD_DEVIATION 9.8 • n=36 Participants	37.1 years STANDARD_DEVIATION 11.4 • n=10 Participants	32.5 years STANDARD_DEVIATION 10.9 • n=115 Participants
Sex: Female, Male Female	9 Participants n=93 Participants	11 Participants n=4 Participants	4 Participants n=27 Participants	9 Participants n=483 Participants	7 Participants n=36 Participants	4 Participants n=10 Participants	44 Participants n=115 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	7 Participants n=483 Participants	11 Participants n=36 Participants	4 Participants n=10 Participants	38 Participants n=115 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	4 Participants n=4 Participants	1 Participants n=27 Participants	1 Participants n=483 Participants	2 Participants n=36 Participants	2 Participants n=10 Participants	10 Participants n=115 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized Black	2 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	4 Participants n=36 Participants	0 Participants n=10 Participants	9 Participants n=115 Participants
Race/Ethnicity, Customized White	12 Participants n=93 Participants	9 Participants n=4 Participants	6 Participants n=27 Participants	11 Participants n=483 Participants	11 Participants n=36 Participants	5 Participants n=10 Participants	54 Participants n=115 Participants
Race/Ethnicity, Customized More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race/Ethnicity, Customized Other	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	1 Participants n=10 Participants	9 Participants n=115 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants	0 Participants n=36 Participants	1 Participants n=10 Participants	9 Participants n=115 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	12 Participants n=93 Participants	15 Participants n=4 Participants	7 Participants n=27 Participants	14 Participants n=483 Participants	18 Participants n=36 Participants	7 Participants n=10 Participants	73 Participants n=115 Participants
Region of Enrollment United States	16 participants n=93 Participants	16 participants n=4 Participants	8 participants n=27 Participants	16 participants n=483 Participants	18 participants n=36 Participants	8 participants n=10 Participants	82 participants n=115 Participants
Body Mass Index (BMI; kg/m^2)	24.6 kg/m^2 STANDARD_DEVIATION 5.5 • n=93 Participants	25.2 kg/m^2 STANDARD_DEVIATION 4.7 • n=4 Participants	28 kg/m^2 STANDARD_DEVIATION 6.9 • n=27 Participants	24.5 kg/m^2 STANDARD_DEVIATION 5.0 • n=483 Participants	24.9 kg/m^2 STANDARD_DEVIATION 3.5 • n=36 Participants	27.1 kg/m^2 STANDARD_DEVIATION 4.6 • n=10 Participants	25.3 kg/m^2 STANDARD_DEVIATION 4.9 • n=115 Participants
Fitzpatrick Skin Scale Extremely Fair Skin	1 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Fitzpatrick Skin Scale Fair Skin	4 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants	5 Participants n=483 Participants	3 Participants n=36 Participants	2 Participants n=10 Participants	20 Participants n=115 Participants
Fitzpatrick Skin Scale Medium Skin	4 Participants n=93 Participants	5 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants	7 Participants n=36 Participants	4 Participants n=10 Participants	26 Participants n=115 Participants
Fitzpatrick Skin Scale Olive Skin	5 Participants n=93 Participants	7 Participants n=4 Participants	2 Participants n=27 Participants	5 Participants n=483 Participants	2 Participants n=36 Participants	1 Participants n=10 Participants	22 Participants n=115 Participants
Fitzpatrick Skin Scale Moderately Brown Skin	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	3 Participants n=36 Participants	1 Participants n=10 Participants	4 Participants n=115 Participants
Fitzpatrick Skin Scale Markedly Black Skin	2 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	2 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	6 Participants n=115 Participants
Fitzpatrick Skin Scale Unknown	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	1 Participants n=36 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Serum Parathyroid Hormone (pg/mL)	37.2 pg/mL STANDARD_DEVIATION 11.8 • n=93 Participants	37.8 pg/mL STANDARD_DEVIATION 13.7 • n=4 Participants	27.6 pg/mL STANDARD_DEVIATION 7.2 • n=27 Participants	31.4 pg/mL STANDARD_DEVIATION 11.8 • n=483 Participants	34.2 pg/mL STANDARD_DEVIATION 8.6 • n=36 Participants	35.6 pg/mL STANDARD_DEVIATION 12.6 • n=10 Participants	34.4 pg/mL STANDARD_DEVIATION 11.4 • n=115 Participants
Serum Calcium (mg/dL)	9.3 mg/dL STANDARD_DEVIATION 0.3 • n=93 Participants	9.4 mg/dL STANDARD_DEVIATION 0.4 • n=4 Participants	9.4 mg/dL STANDARD_DEVIATION 0.4 • n=27 Participants	9.3 mg/dL STANDARD_DEVIATION 0.4 • n=483 Participants	9.5 mg/dL STANDARD_DEVIATION 0.3 • n=36 Participants	9.2 mg/dL STANDARD_DEVIATION 0.3 • n=10 Participants	9.4 mg/dL STANDARD_DEVIATION 0.4 • n=115 Participants
Total Serum Immunoglobulin E (IgE)	68.4 kU/L STANDARD_DEVIATION 127.3 • n=93 Participants	1870.1 kU/L STANDARD_DEVIATION 3310.5 • n=4 Participants	85.1 kU/L STANDARD_DEVIATION 82.0 • n=27 Participants	45.7 kU/L STANDARD_DEVIATION 58.8 • n=483 Participants	724.9 kU/L STANDARD_DEVIATION 2030.6 • n=36 Participants	69.7 kU/L STANDARD_DEVIATION 109.0 • n=10 Participants	553.3 kU/L STANDARD_DEVIATION 1825.2 • n=115 Participants

PRIMARY outcome

Timeframe: Baseline to Day 21

Outcome measures

Outcome measures
Measure	Vitamin D (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
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 Lesional Skin Type	-0.4 Cycle Number Standard Deviation 2.8	0.1 Cycle Number Standard Deviation 2.4
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 Non-Lesional Skin Type	-0.6 Cycle Number Standard Deviation 2.0	0.7 Cycle Number Standard Deviation 2.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
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	1.2 Cycle Number Standard Deviation 2.4	0.3 Cycle Number Standard Deviation 1.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D (AD) n=8 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (AD) n=8 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
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 Lesional Skin Type	-0.9 Cycle Number Standard Deviation 3.0	0.2 Cycle Number Standard Deviation 3.2
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 Non-Lesional Skin Type	-0.6 Cycle Number Standard Deviation 2.3	0.7 Cycle Number Standard Deviation 2.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
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 Lesional Skin Type	-0.1 Cycle Number Standard Deviation 7.3	-0.8 Cycle Number Standard Deviation 2.8
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 Non-Lesional Skin Type	-0.1 Cycle Number Standard Deviation 3.5	1.4 Cycle Number Standard Deviation 3.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
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	0.2 Cycle Number Standard Deviation 2.8	1.2 Cycle Number Standard Deviation 3.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D (AD) n=8 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (AD) n=8 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
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 Lesional Skin Type	0.8 Cycle Number Standard Deviation 5.3	-1.6 Cycle Number Standard Deviation 4.4
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 Non-Lesional Skin Type	-1.5 Cycle Number Standard Deviation 3.2	-1.5 Cycle Number Standard Deviation 4.3

SECONDARY outcome

Timeframe: Baseline to Day 21

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.

Outcome measures

Outcome measures
Measure	Vitamin D (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
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 Lesional Skin Type	-0.7 Cycle Number Standard Deviation 2.8	1.1 Cycle Number Standard Deviation 2.7
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 Non-Lesional Skin Type	-0.8 Cycle Number Standard Deviation 2.3	-0.1 Cycle Number Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline to Day 21

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.

Outcome measures

Outcome measures
Measure	Vitamin D (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3 (cholecalciferol, 4,000 IU daily).	Placebo (AD) n=15 Participants Participants classified as atopic dermatitis (AD) as defined by the Atopic Dermatitis and Vaccinia Network (ADVN) Standard Diagnostic Criteria. Participants received a 21-day course of oral vitamin D3- placebo.
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	0.2 Cycle Number Standard Deviation 2.4	0.5 Cycle Number Standard Deviation 1.5

SECONDARY outcome

Timeframe: Baseline to Day 21

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.