Atopic DermatitisNCT02058186
Effect of Oral Vitamin D Supplement on Atopic Dermatitis; A Clinical Trial With Staphylococcus Aureus Colonization Determination
A study testing oral vitamin D in people with Atopic Dermatitis, run by Srinakharinwirot University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- oral vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Skin Center, Srinakharinwirot University
Bangkok, Bangkok, 10110
About this study
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
- Being tested
- oral vitamin D, Placebo
- Keywords
- Atopic dermatitis, vitamin D supplementation, cathelicidin, Staphylococcus aureus colonization, SCORAD score
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral vitamin DDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis patients: Active | Active comparator | Atopic dermatitis patients: age 1-18 years old Receives: Drug: oral vitamin D |
| Atopic dermatitis patients: Placebo | Placebo comparator | Atopic dermatitis patients: age 1-18 years old Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCORAD score
Measured: May - August 2012 (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startDec 2011
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Srinakharinwirot University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montree Udompataikul, Srinakharinwirot University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02058186
- Sponsor's protocol ID
- 218/2555
- Status last verified
- Feb 2014
- First submitted
- 6 Feb 2014
- Last updated
- 7 Feb 2014
- Results posted
- No
Publications
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.
PubMed 33305842
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Vitamin D Supplement on Atopic Dermatitis; A Clinical Trial With Staphylococcus Aureus Colonization Determination
- ClinicalTrials.gov ID
- NCT02058186
- Acronym / sponsor ID
- 218/2555
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, vitamin D supplementation, cathelicidin, Staphylococcus aureus colonization, SCORAD score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Srinakharinwirot UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis patients: Active | Active comparator | Drug: oral vitamin DAtopic dermatitis patients: age 1-18 years old |
| Atopic dermatitis patients: Placebo | Placebo comparator | Drug: PlaceboAtopic dermatitis patients: age 1-18 years old |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral vitamin D | Drug | Atopic dermatitis patients: Active |
| Placebo | Drug | Atopic dermatitis patients: Placebo |
Primary outcome
SCORAD score
Time frame: May - August 2012 (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
- Derived from this study: PubMed 33305842Huey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral vitamin D in people with Atopic Dermatitis, run by Srinakharinwirot University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCORAD score (time frame: May - August 2012 (3 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02058186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2014.