Atopic DermatitisVIDATOPICNCT01996423
Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis
A study testing Vitamin D3 in people with Atopic Dermatitis, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The purpose of this study is to determine whether oral vitamin D supplementation improves the clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate the effects of vitamin D supplementation on several key aspects of the immune system of children with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteChile
- Study dates
- Apr 2014to Dec 2014
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Atopic dermatitis diagnosed according to Hanifin and Rajka criteria
- Age 2 - 17 years
- SCORAD 10 - 103
Who cannot join
- Active skin infection
- History of underlying illness causing immunosuppression within the past 2 years
- Immunosuppressors taken within the past month
- Parathyroid disease
- Sarcoidosis
- Acute or chronic renal disease
Show all 16Show fewer
- Hyper or hypocalcemia
- Thyroid disease
- Osteomalacia or Paget's disease of bone
- Malabsorption
- Use of VD supplements (> 400 IU daily) or fish oil supplements in the past month
- Treatment for known VD deficiency in the last 6 months
- Treatment with moderate or high potency topical corticosteroids, oral or topical antibiotics, oral antivirals, immune enhancers, or topical calcineurin inhibitors in the past 7 days
- Phototherapy in the past month
- Autoimmune disease or immunodeficiency
- Planned trip to sunny climate during the 6-week study.
Trial locations and contacts
1 site in 1 country.
Chile1 site
School of Medicine, Pontificia Universidad Católica de Chile
Santiago
About this study
Official title: Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis
The purpose of this study is to determine whether oral vitamin D supplementation improves the clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate the effects of vitamin D supplementation on several key aspects of the immune system of children with atopic dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Vitamin D3, Placebo
- Keywords
- Atopic dermatitis, vitamin D
- 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 D3Dietary supplement
Also called Cholecalciferol
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 supplementation | Experimental | Subjects in the experimental arm will receive weekly vitamin D3 doses in oral suspension during 6 weeks. Weekly dose varies according to age group: VD3 8000 IU between ages 2-5.9 years, VD3 12000 IU between ages 6-11.9 years, VD3 16000 IU between ages 12-17.9 years. Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Subjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in SCORAD index
Change in Scoring Atopic Dermatitis (SCORAD) index after 6 weeks of vitamin D3 (VD3) supplementation or placebo in children with atopic dermatitis.
Measured: baseline and 6 weeks
Secondary outcomes (5)
Changes in Th2 immunity
Eosinophil blood counts, serum IgE, Th2 lymphocytes among stimulated PBMCs, serum CCL17, CCL22, and CCL27.
Measured: baseline and 6 weeks
Change in dendritic cell-mediated tolerance and regulatory T cells
Number and phenotype of blood dendritic cells and number of regulatory T cells.
Measured: baseline and 6 weeks
Effect of VD3 supplementation on immunity to Staphylococcus aureus
Serum cathelicidin levels, S. aureus skin carriage, and specific IgE to staphylococcal enterotoxins.
Measured: baseline and 6 weeks
Vitamin D receptor single nucleotide polymorphisms
Effect of VDR SNPs on the VD3 response.
Measured: baseline and 6 weeks
Change in epidermal protein expression
Gene expression of epidermal proteins by PCR obtained from lesional and non-lesional tape stripping samples.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
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.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arturo Borzutzky, M.D., Principal investigator, School of Medicine, Pontificia Universidad Católica de ChileCarlos A Camargo Jr., M.D., DrPH, Study director, Massachusetts General Hospital, Harvard University, Boston, USACristian Vera, M.D., Study director, School of Medicine, Pontificia Universidad Católica de ChileLorena Cifuentes, M.D., Study director, School of Medicine, Pontificia Universidad Católica de ChileSergio Silva, M.D., Study director, School of Medicine, Pontificia Universidad Católica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996423
- Sponsor's protocol ID
- 12-185
- Other IDs
- 1130615
- Acronym
- VIDATOPIC
- Status last verified
- Feb 2015
- First submitted
- 11 Nov 2013
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Borzutzky A, Iturriaga C, Perez-Mateluna G, Cristi F, Cifuentes L, Silva-Valenzuela S, Vera-Kellet C, Cabalin C, Hoyos-Bachiloglu R, Navarrete-Dechent C, Cossio ML, Le Roy C, Camargo CA Jr. Effect of weekly vitamin D supplementation on the severity of atopic dermatitis and type 2 immunity biomarkers in children: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2024 Sep;38(9):1760-1768. doi: 10.1111/jdv.19959. Epub 2024 Mar 14.
PubMed 38483248
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01996423
- Acronym / sponsor ID
- VIDATOPIC / 12-185
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Nov 2013 (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.
The purpose of this study is to determine whether oral vitamin D supplementation improves the clinical severity of atopic dermatitis in children. In addition, this study plans to evaluate the effects of vitamin D supplementation on several key aspects of the immune system of children with atopic dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 supplementation | Experimental | Dietary Supplement: Vitamin D3Subjects in the experimental arm will receive weekly vitamin D3 doses in oral suspension during 6 weeks. Weekly dose varies according to age group: VD3 8000 IU between ages 2-5.9 years, VD3 12000 IU between ages 6-11.9 years, VD3 16000 IU between ages 12-17.9 years. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboSubjects in the placebo arm will receive weekly placebo oral suspension during 6 weeks. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Atopic dermatitis diagnosed according to Hanifin and Rajka criteria
- Age 2 - 17 years
- SCORAD 10 - 103
Key exclusion criteria (16 listed)
- Active skin infection
- History of underlying illness causing immunosuppression within the past 2 years
- Immunosuppressors taken within the past month
- Parathyroid disease
- Sarcoidosis
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 D3Also: Cholecalciferol | Dietary supplement | Vitamin D3 supplementation |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Change in SCORAD index
Time frame: baseline and 6 weeks
Change in Scoring Atopic Dermatitis (SCORAD) index after 6 weeks of vitamin D3 (VD3) supplementation or placebo in children with atopic dermatitis.
5 secondary outcomes
Changes in Th2 immunity
Time frame: baseline and 6 weeks
Change in dendritic cell-mediated tolerance and regulatory T cells
Time frame: baseline and 6 weeks
Effect of VD3 supplementation on immunity to Staphylococcus aureus
Time frame: baseline and 6 weeks
Vitamin D receptor single nucleotide polymorphisms
Time frame: baseline and 6 weeks
Change in epidermal protein expression
Time frame: 6 weeks
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 3 Mar 2015.
- Derived from this study: PubMed 38483248Borzutzky A, Iturriaga C, Perez-Mateluna G, Cristi F, Cifuentes L, Silva-Valenzuela S, Vera-Kellet C, Cabalin C, Hoyos-Bachiloglu R, Navarrete-Dechent C, Cossio ML, Le Roy C, Camargo CA Jr. Effect of weekly vitamin D supplementation on the severity of atopic dermatitis and type 2 immunity biomarkers in children: A randomized controlled trial. J Eur Acad Dermatol Venereol. 2024 Sep;38(9):1760-1768. doi: 10.1111/jdv.19959. Epub 2024 Mar 14.
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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.
Arturo Borzutzky, M.D. principal investigator
School of Medicine, Pontificia Universidad Católica de Chile
Carlos A Camargo Jr., M.D., DrPH study director
Massachusetts General Hospital, Harvard University, Boston, USA
Cristian Vera, M.D. study director
School of Medicine, Pontificia Universidad Católica de Chile
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 D3 in people with Atopic Dermatitis, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 3 inclusion and 16 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 3 Mar 2015. 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 Chile. 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?
Change in SCORAD index (time frame: baseline and 6 weeks). 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 NCT01996423, 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 3 Mar 2015.