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

Not Applicable

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: oral vitamin D; Drug: Placebo

• Registration Number: NCT02058186
• Lead Sponsor: Srinakharinwirot University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2012-12
• Status Verified: 2014-02
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Study First Posted: 2014-02-07
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• The exclusion criteria were to coexisting skin infection on top with AD lesions, known case of primary or secondary immune-compromised host, hepatic or renal disease, those taking vitamin D or nutraceutical supplementation, those continues taking with antibiotics, corticosteroid, immunosuppressive agents, anti-epileptic drugs, thiazide diuretics, proton-pump inhibitors, histamine 2-receptor antagonists at the time of enrollment. Patients who used topical antiseptic or antibiotic products during study period were also excluded. Patients who developed worsening of AD with flare-up of clinical manifestation or SCORAD greater than 40, secondary infection on-top tested lesions were excluded from data analysis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Atopic dermatitis patients: Active	oral vitamin D	Atopic dermatitis patients: age 1-18 years old
Atopic dermatitis patients: Placebo	Placebo	Atopic dermatitis patients: age 1-18 years old

Primary Outcome Measures

Name	Time	Method
SCORAD score	May - August 2012 (3 months)

Trial Locations

Locations (1)

Skin Center, Srinakharinwirot University; 🇹🇭 Bangkok, Thailand