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Vitamin D in Egyptian Children With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Vitamin D
Placebo
Sponsored by
National Hepatology & Tropical Medicine Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

5 Years - 16 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • NHTRMI

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

treatment group

placebo group

Arm Description

vitamin D plus topical 1% hydrocortisone cream twice daily

placebo plus plus topical 1% hydrocortisone cream twice daily

Outcomes

Primary Outcome Measures

difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study
the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study

Secondary Outcome Measures

Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score
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
EASI 50
Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score
EASI<50

Full Information

First Posted
July 9, 2020
Last Updated
July 10, 2020
Sponsor
National Hepatology & Tropical Medicine Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04468711
Brief Title
Vitamin D in Egyptian Children With Atopic Dermatitis
Official Title
The Impact of Vitamin D Supplementation as an Adjuvant Therapy on Clinical Outcome in Patients With Severe Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
June 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Hepatology & Tropical Medicine Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
vitamin D plus topical 1% hydrocortisone cream twice daily
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo plus plus topical 1% hydrocortisone cream twice daily
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
plus topical 1% hydrocortisone cream twice daily
Intervention Description
Vitamin D plus topical 1% hydrocortisone cream twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo plus topical 1% hydrocortisone cream twice daily
Primary Outcome Measure Information:
Title
difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study
Time Frame
12 weeks
Title
the average percent change in Eczema Area and Severity Index (EASI) score at the end of the study
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Difference in proportion of patients with a reduction from baseline of 75 % in Eczema Area and Severity Index (EASI) score
Description
EASI 75
Time Frame
12 weeks
Title
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
Description
EASI 50
Time Frame
12 weeks
Title
Difference in proportion of patients with a reduction from baseline of <50 n Eczema Area and Severity Index (EASI) score
Description
EASI<50
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.diagnosis of severe AD according to Hanifin and Rajka criteria and the Eczema Area and Severity Index (EASI) score Exclusion Criteria: 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.
Facility Information:
Facility Name
NHTRMI
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Vitamin D in Egyptian Children With Atopic Dermatitis

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