Vitamin D in Egyptian Children With Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

The Impact of Vitamin D Supplementation as an Adjuvant Therapy on Clinical Outcome in Patients With Severe Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468711
• Other study ID #: 12-2018
• Status: Completed
• Phase: Phase 3
• Start date: June 6, 2018
• Est. completion date: June 4, 2019

Study information

• Verified date: July 2020
• Source: National Hepatology & Tropical Medicine Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: June 4, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Vitamin D
Vitamin D plus topical 1% hydrocortisone cream twice daily
• Placebo
placebo plus topical 1% hydrocortisone cream twice daily

Locations

Country	Name	City	State
Egypt	NHTRMI	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Hepatology & Tropical Medicine Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study		12 weeks
Primary	the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study		12 weeks
Secondary	Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score	EASI 75	12 weeks
Secondary	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	12 weeks
Secondary	Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score	EASI<50	12 weeks