Atopic DermatitisNCT05523986
Vitamin D Treatment Effect for Atopic Dermatitis in Children
A study testing Vitamin D in people with Atopic Dermatitis, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
A double-blind study to evaluate the role of human microbiome and vitamin D in the development of atopic dermatitis. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Aug 2022to 30 Jun 2025
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Experimental group: Patients were 1-18 years old with EASI score moderate to severe atopic dermatitis, and atopic dermatitis was defined as three or more of the following statements to be diagnosed as atopic dermatitis:
- skin itching
- typical skin symptoms (including eczematous dermatitis or lichenified dermatitis) and location (mostly on the extensor side of the face and body in infants and young children, and on the flexor side of joints in adults)
- chronic persistent or recurrent dermatitis for more than 6 months.
- Individuals or family members with atopic constitution such as allergic rhinitis, asthma, atopic dermatitis or urticaria.
- Control group:healthy children under the age of 18 (eg, healthy siblings of sick children).
Who cannot join
- Less than 1 year old or more than 18 years old.
- Patients with mild EASI severity of atopic dermatitis.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Jiu-Yao Wang, MD, 886422052121 ext. 4131, aim.cmuh@gmail.com
About this study
A double-blind study to evaluate the role of human microbiome and vitamin D in the development of atopic dermatitis.
Read the detailed description
Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disease with intermittent flares, affecting approximately 15% to 20% worldwide. Atopic dermatitis is clinically distinguished by pruritus, eczematous plaques, and a defective epidermal barrier. The pathology of AD is not entirely understood. It involves a complex interplay of dysfunctions of immune response, genetic and environmental factors (such as exposure to allergens and microbes). The control of patients with AD may be difficult to be achieved in some patients; this suggests the presence of some other associated factors. The findings obtained in both clinical and observational studies revealed that the deficiency of vitamin D may be a factor to be considered in the pathophysiology of AD. Vitamin D supplementation with standard treatment yielded positive clinical outcomes in mild and moderate AD. However, the potential benefit of vitamin D and its clinical correlation in AD is still uncertain. Thus, there is a need for more detailed and prospective studies.
The investigators will enroll children with atopic dermatitis and age and gender matched healthy children in China Medical University Children's Hospital. Briefly, the investigators interviewed subjects using EASI SCORE (defined as moderate or severe patients) and collected their venous blood and microbiome samples of nasal, skin and anal swab. Then, AD subjects will be given vitamin D or placebo for 6 months in a randomized, double-blind way. The participants will be asked to return to the outpatient clinic every month to assess the severity of AD. After six months of follow-up, their blood, nasal cavity, skin and intestinal bacterial samples were taken. All microbial analysis, allergen detection, vitamin D concentration, VDR, and DBP genotype will be analyzed by the core laboratory and bioinformatics center of CMUH.
The investigators believe this study can answer the cause-effect relationships of microbiota and vitamin D in the development of AD, and design a microbiota-related preventive and treatment strategy.
- Conditions
- Atopic Dermatitis
- Being tested
- Vitamin D, Placebo
- Keywords
- atopic dermatitis, human microbiome, vitamin D, vitamin D receptors and vitamin D binding protein
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DOther
Vitamin D (2000IU/day) for 6 months
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment group | Experimental | Vitamin D (2000IU/day) for 6 months Receives: Other: Vitamin D |
| Placebo Comparator: Control group | Placebo comparator | placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of vitamin D
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Measured: Month 0
Levels of vitamin D
Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.
Measured: Month 6
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Measured: Month 0
Microbiome Microbiome
Nasal, skin and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
Measured: Month 0
Microbiome Microbiome
Nasal, skin and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing,and to follow the change from baseline in microbiome at month 6.
Measured: Month 6
Total IgE
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.
Measured: Month 0
Total IgE
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to follow the change from baseline in total IgE at month 6.
Measured: Month 6
Allergen-specific IgE
Plasma allergen-specific IgE will be measured by BioIC ®.
Measured: Month 0
Secondary outcomes (2)
The Eczema Area and Severity Index (EASI)
EASI range is from 0 to 72, the minimum value is "0" and maximum value is "72", higher scores mean a worse outcome.
Measured: Month 0 to Month 6
Patient Oriented Eczema Measure (POEM)
This survey is a total of 7 questions that assesses the quality of life of patient's with eczema to determine their disease severity. The 7 questions are scored out of 4 points. A higher total score indicates a higher severity of disease.
Measured: Month 0 to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start9 Aug 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523986
- Sponsor's protocol ID
- CMUH111-REC1-111
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Treatment Effect for Atopic Dermatitis in Children
- ClinicalTrials.gov ID
- NCT05523986
- Acronym / sponsor ID
- CMUH111-REC1-111
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, human microbiome, vitamin D, vitamin D receptors and vitamin D binding protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 1 Sep 2022 (actual)
- 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.
A double-blind study to evaluate the role of human microbiome and vitamin D in the development of atopic dermatitis.
Detailed description
Atopic dermatitis (AD) is a chronic relapsing inflammatory skin disease with intermittent flares, affecting approximately 15% to 20% worldwide. Atopic dermatitis is clinically distinguished by pruritus, eczematous plaques, and a defective epidermal barrier. The pathology of AD is not entirely understood. It involves a complex interplay of dysfunctions of immune response, genetic and environmental factors (such as exposure to allergens and microbes). The control of patients with AD may be difficult to be achieved in some patients; this suggests the presence of some other associated factors. The findings obtained in both clinical and observational studies revealed that the deficiency of vitamin D may be a factor to be considered in the pathophysiology of AD. Vitamin D supplementation with standard treatment yielded positive clinical outcomes in mild and moderate AD. However, the potential benefit of vitamin D and its clinical correlation in AD is still uncertain. Thus, there is a need for more detailed and prospective studies.
The investigators will enroll children with atopic dermatitis and age and gender matched healthy children in China Medical University Children's Hospital. Briefly, the investigators interviewed subjects using EASI SCORE (defined as moderate or severe patients) and collected their venous blood and microbiome samples of nasal, skin and anal swab. Then, AD subjects will be given vitamin D or placebo for 6 months in a randomized, double-blind way. The participants will be asked to return to the outpatient clinic every month to assess the severity of AD. After six months of follow-up, their blood, nasal cavity, skin and intestinal bacterial samples were taken. All microbial analysis, allergen detection, vitamin D concentration, VDR, and DBP genotype will be analyzed by the core laboratory and bioinformatics center of CMUH.
The investigators believe this study can answer the cause-effect relationships of microbiota and vitamin D in the development of AD, and design a microbiota-related preventive and treatment strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment group | Experimental | Other: Vitamin DVitamin D (2000IU/day) for 6 months |
| Placebo Comparator: Control group | Placebo comparator | Other: Placeboplacebo |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Experimental group: Patients were 1-18 years old with EASI score moderate to severe atopic dermatitis, and atopic dermatitis was defined as three or more of the following statements to be diagnosed as atopic dermatitis:
- skin itching
- typical skin symptoms (including eczematous dermatitis or lichenified dermatitis) and location (mostly on the extensor side of the face and body in infants and young children, and on the flexor side of joints in adults)
- chronic persistent or recurrent dermatitis for more than 6 months.
- Individuals or family members with atopic constitution such as allergic rhinitis, asthma, atopic dermatitis or urticaria.
Key exclusion criteria (2 listed)
- Less than 1 year old or more than 18 years old.
- Patients with mild EASI severity of atopic dermatitis.
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 |
|---|---|---|
| Vitamin DVitamin D (2000IU/day) for 6 months | Other | Experimental: Treatment group |
| PlaceboPlacebo | Other | Placebo Comparator: Control group |
Primary outcome
Levels of vitamin D
Time frame: Month 0
Vitamin D will be measured in a blood sample by ELISA to determine baseline status.
Levels of vitamin D
Time frame: Month 6
Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein
Time frame: Month 0
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Microbiome Microbiome
Time frame: Month 0
Nasal, skin and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
Microbiome Microbiome
Time frame: Month 6
Nasal, skin and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing,and to follow the change from baseline in microbiome at month 6.
Total IgE
Time frame: Month 0
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to determine baseline status.
Total IgE
Time frame: Month 6
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to follow the change from baseline in total IgE at month 6.
Allergen-specific IgE
Time frame: Month 0
Plasma allergen-specific IgE will be measured by BioIC ®.
2 secondary outcomes
The Eczema Area and Severity Index (EASI)
Time frame: Month 0 to Month 6
Patient Oriented Eczema Measure (POEM)
Time frame: Month 0 to Month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Atopic Dermatitis, run by China Medical University Hospital at 1 site in Taiwan.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Sep 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiu-Yao Wang, MD (886422052121 ext. 4131, aim.cmuh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of vitamin D (time frame: Month 0). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2023.