Vitamin D in Egyptian Children With Atopic Dermatitis

July 10, 2020 updated by: Noha Mansour, National Hepatology & Tropical Medicine Research Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • NHTRMI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: treatment group
vitamin D plus topical 1% hydrocortisone cream twice daily
Drug: Vitamin D
Vitamin D plus topical 1% hydrocortisone cream twice daily
Other Names:
  • plus topical 1% hydrocortisone cream twice daily
Placebo Comparator: placebo group
placebo plus plus topical 1% hydrocortisone cream twice daily
Drug: Placebo
placebo plus topical 1% hydrocortisone cream twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study
Time Frame: 12 weeks
12 weeks
the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score
Time Frame: 12 weeks
EASI 75
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
Time Frame: 12 weeks
EASI 50
12 weeks
Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score
Time Frame: 12 weeks
EASI<50
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Hepatology & Tropical Medicine Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2018

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

June 4, 2019

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 13, 2020

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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