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
1 other identifier
interventional
92
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2018
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2019
CompletedFirst Submitted
Initial submission to the registry
July 9, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedJuly 14, 2020
July 1, 2020
6 months
July 9, 2020
July 10, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score
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
12 weeks
Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score
12 weeks
Study Arms (2)
treatment group
ACTIVE COMPARATORvitamin D plus topical 1% hydrocortisone cream twice daily
placebo group
PLACEBO COMPARATORplacebo plus plus topical 1% hydrocortisone cream twice daily
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score
You may not qualify if:
- serious skin disorder other than AD.
- taking systemic corticosteroids or anti-inflammatory medications, prior vitamin D supplementation
- receiving oral or topical antibiotics or topical calcineurin inhibitors for at least one week prior to enrollment
- known gut absorption problem, presence of active skin infection at baseline any known hepatic and/or renal disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NHTRMI
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 13, 2020
Study Start
June 6, 2018
Primary Completion
December 1, 2018
Study Completion
June 4, 2019
Last Updated
July 14, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share