Vitamin D in Egyptian Children With Atopic Dermatitis

National Hepatology & Tropical Medicine Research Institute92 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Vitamin DDRUG

Vitamin D plus topical 1% hydrocortisone cream twice daily

PlaceboDRUG

placebo plus topical 1% hydrocortisone cream twice daily

Eligibility

Sex: ALLMin age: 5 YearsMax age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score Exclusion Criteria: 1. serious skin disorder other than AD. 2. taking systemic corticosteroids or anti-inflammatory medications, prior vitamin D supplementation 3. receiving oral or topical antibiotics or topical calcineurin inhibitors for at least one week prior to enrollment 4. known gut absorption problem, presence of active skin infection at baseline any known hepatic and/or renal disease.

Locations (1)

NHTRMI

Cairo, Egypt

Outcomes

Primary Outcomes

difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study

Time frame: 12 weeks

the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study

Time frame: 12 weeks

Secondary Outcomes

Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score

EASI 75

Time frame: 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

EASI 50

Time frame: 12 weeks

Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score

EASI\<50

Time frame: 12 weeks

Data from ClinicalTrials.gov

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