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OpenTrials
Completed

NCT Number: NCT04468711

Vitamin D in Egyptian Children With 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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NHTRMI

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D

Drug

Vitamin D plus topical 1% hydrocortisone cream twice daily

Other names: plus topical 1% hydrocortisone cream twice daily

Placebo

Drug

placebo plus topical 1% hydrocortisone cream twice daily

Primary outcomes

  1. difference in the mean Eczema Area and Severity Index (EASI) score at the end of the study

    Time frame: 12 weeks

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

    Time frame: 12 weeks

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

National Hepatology & Tropical Medicine Research Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 13, 2020
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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