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There is an emergent evidence demonstrating the role of Vitamin D deficiency in eczema. Vitamin D supplementation with standard treatment yielded positive clinical outcomes for children and adolescents with mild and moderate AD; however, the potential benefit of vitamin D in severe cases remains unclear
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Active Comparator | vitamin D plus topical 1% hydrocortisone cream twice daily |
|
| placebo group | Placebo Comparator | placebo plus plus topical 1% hydrocortisone cream twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Vitamin D plus topical 1% hydrocortisone cream twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study | 12 weeks | |
| the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score | EASI 75 | 12 weeks |
| Difference in proportion of patients with a reduction from baseline of (50 or more up to 75) in Eczema Area and Severity Index (EASI) score |
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Inclusion Criteria:
1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHTRMI | Cairo | Egypt |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| 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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| Placebo | Drug | placebo plus topical 1% hydrocortisone cream twice daily |
|
EASI 50 |
| 12 weeks |
| Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score | EASI<50 | 12 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |