Vitamin D in Egyptian Children With Atopic Dermatitis

National Hepatology & Tropical Medicine Research Institute

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Vitamin D; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04468711

12-2018

Details and patient eligibility

About

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

Enrollment: 92 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

treatment group

Active Comparator group

Description:

vitamin D plus topical 1% hydrocortisone cream twice daily

Treatment:

Drug: Vitamin D

placebo group

Placebo Comparator group

Description:

placebo plus plus topical 1% hydrocortisone cream twice daily

Treatment:

Drug: Placebo