Effect of Oral Vitamin D Supplement on Atopic Dermatitis; A Clinical Trial With Staphylococcus Aureus Colonization Determination

NCT02058186 | Completed

• 1 other identifier: 218/2555
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Increase in skin colonization of Staphylococcus aureus (S. aureus) in atopic dermatitis patients (AD) resulted from the reduction of cathelicidin production in these patients plays the important role in pathogenesis of this disease. Recently in vivo study has showed that vitamin D can stimulate cathelicidin production. Oral supplement of vitamin D might be beneficial in atopic dermatitis. Objective: To determine the effect of oral vitamin D supplement on clinical impact including skin colonization of S. aureus in atopic dermatitis patients.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, vitamin D supplementation, cathelicidin, Staphylococcus aureus colonization, SCORAD score

Outcome Measures

Primary Outcomes (1)

• SCORAD score

  May - August 2012 (3 months)

Study Arms (2)

Atopic dermatitis patients: Active

ACTIVE COMPARATOR

Atopic dermatitis patients: age 1-18 years old

Drug: oral vitamin D

Atopic dermatitis patients: Placebo

PLACEBO COMPARATOR

Atopic dermatitis patients: age 1-18 years old

Drug: Placebo

Interventions

oral vitamin D DRUG

Atopic dermatitis patients: Active

Placebo DRUG

Atopic dermatitis patients: Placebo

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Eligible criteria included patients with mild to moderate atopic dermatitis by SCORAD (Scoring for Atopic Dermatitis) score criteria1,17,18, age between 1-18 years old. All patients had been advised to take normal, dietary product and their activities. They had been advised to discontinue at least 4 weeks of oral corticosteroid, at least 2 weeks of topical corticosteroid or topical calcineurin inhibitor application and at least 6 months of vitamin supplement prior to starting the protocol

Sponsors & Collaborators

• Srinakharinwirot University: lead

Study Sites (1)

Skin Center, Srinakharinwirot University

Bangkok, Bangkok, 10110, Thailand

Location

Related Publications (1)

• Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.

  PMID: 33305842 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Skin Center

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: February 7, 2014
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Last Updated: February 7, 2014

Record last verified: 2014-02

Locations

TH (1)