Vitamin D in Egyptian Children With Atopic Dermatitis

NCT ID: NCT04468711

Last Updated: 2020-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2019-06-04

Brief Summary

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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

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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treatment group

vitamin D plus topical 1% hydrocortisone cream twice daily

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

Vitamin D plus topical 1% hydrocortisone cream twice daily

placebo group

placebo plus plus topical 1% hydrocortisone cream twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo plus topical 1% hydrocortisone cream twice daily

Interventions

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Vitamin D

Vitamin D plus topical 1% hydrocortisone cream twice daily

Intervention Type DRUG

Placebo

placebo plus topical 1% hydrocortisone cream twice daily

Intervention Type DRUG

Other Intervention Names

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plus topical 1% hydrocortisone cream twice daily

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Hepatology & Tropical Medicine Research Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Noha Mansour

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NHTRMI

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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12-2018

Identifier Type: -

Identifier Source: org_study_id

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