Vitamin D in Egyptian Children With Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Placebo; Drug: Vitamin D

• Registration Number: NCT04468711
• Lead Sponsor: National Hepatology & Tropical Medicine Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-06
• Primary Completion: 2018-12-01
• Study Completion: 2019-06-04
• Status Verified: 2020-07
• Study First Submitted: 2020-07-09
• Study First Submitted QC: 2020-07-10
• Last Update Submitted: 2020-07-10
• Study First Posted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	placebo plus plus topical 1% hydrocortisone cream twice daily
treatment group	Vitamin D	vitamin D plus topical 1% hydrocortisone cream twice daily

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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	12 weeks	EASI 50
Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score	12 weeks	EASI\<50
Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score	12 weeks	EASI 75

Trial Locations

Locations (1)

NHTRMI; 🇪🇬 Cairo, Egypt