search
Back to results

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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
oral vitamin D
Placebo
Sponsored by
Srinakharinwirot University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, vitamin D supplementation, cathelicidin, Staphylococcus aureus colonization, SCORAD score

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Skin Center, Srinakharinwirot University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atopic dermatitis patients: Active

Atopic dermatitis patients: Placebo

Arm Description

Atopic dermatitis patients: age 1-18 years old

Atopic dermatitis patients: age 1-18 years old

Outcomes

Primary Outcome Measures

SCORAD score

Secondary Outcome Measures

Full Information

First Posted
February 6, 2014
Last Updated
February 6, 2014
Sponsor
Srinakharinwirot University
search

1. Study Identification

Unique Protocol Identification Number
NCT02058186
Brief Title
Effect of Oral Vitamin D Supplement on Atopic Dermatitis; A Clinical Trial With Staphylococcus Aureus Colonization Determination
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Srinakharinwirot University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, vitamin D supplementation, cathelicidin, Staphylococcus aureus colonization, SCORAD score

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atopic dermatitis patients: Active
Arm Type
Active Comparator
Arm Description
Atopic dermatitis patients: age 1-18 years old
Arm Title
Atopic dermatitis patients: Placebo
Arm Type
Placebo Comparator
Arm Description
Atopic dermatitis patients: age 1-18 years old
Intervention Type
Drug
Intervention Name(s)
oral vitamin D
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
SCORAD score
Time Frame
May - August 2012 (3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Skin Center, Srinakharinwirot University
City
Bangkok
ZIP/Postal Code
10110
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
33305842
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs