Vitamin D in Egyptian Children With Atopic Dermatitis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04468711

Enrollment

Registered

2020-07-13

Start date

2018-06-06

Completion date

2019-06-04

Last updated

2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

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

Interventions

DRUGVitamin D

Vitamin D plus topical 1% hydrocortisone cream twice daily

DRUGPlacebo

placebo plus topical 1% hydrocortisone cream twice daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to 16 Years

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.

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame	Description
Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score	12 weeks	EASI 75
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026