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Not meeting enrollment goals.
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| Name | Class |
|---|---|
| Children's Hospital and Health System Foundation, Wisconsin | OTHER |
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Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier, inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble vitamin that is primarily acquired through local production in the skin after ultraviolet light exposure but can also be obtained through natural and supplemental dietary sources. This randomized controlled trial will examine the effects of vitamin D repletion on atopic dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will have improved cutaneous disease after treatment with high dose as compared to standard dose vitamin D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose vitamin D | Active Comparator | Treatment with cholecalciferol 400 IU daily at home. |
|
| High dose vitamin D | Active Comparator | Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atopic Dermatitis Severity at the Completion of Treatment | SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Restart Topical Steroids | The time to restart topical steroids. | 6 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yvonne Chiu, MD | Children's Hospital and Health System Foundation, Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Dose Vitamin D | Treatment with cholecalciferol 400 IU daily at home. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks |
| FG001 | High Dose Vitamin D | Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Dose Vitamin D | Treatment with cholecalciferol 400 IU oral daily at home for 6 weeks |
| BG001 | High Dose Vitamin D | Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Atopic Dermatitis Severity at the Completion of Treatment | SCORAD at the 6 week study visit. The SCORAD (SCORing Atopic Dermatitis) is a clinical tool used to assess the extent and severity of eczema. The SCORAD is scored 0-103, with a higher score indicating more severe atopic dermatitis (worse outcome). | Posted | Mean | Full Range | score on a scale | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Dose Vitamin D | Treatment with cholecalciferol 400 IU daily at home. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yvonne Chiu, MD | Medical College of Wisconsin | 414-955-2818 | ychiu@mcw.edu |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Restart Topical Steroids | The time to restart topical steroids. | Posted | Mean | Full Range | days | 6 weeks |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | High Dose Vitamin D | Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic. Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks | 0 | 4 | 0 | 4 |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |