Clinical trial NCT01996423: Impact of Vitamin D Supplementation on Severity of Pediatric Atopic Dermatitis
Official title: Impact of Vitamin D Supplementation on Clinical Severity and Immunologic Tolerance of Pediatric Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
vitamin D
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 101
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Atopic dermatitis diagnosed according to Hanifin and Rajka criteria
* Age 2 - 17 years
* SCORAD 10 - 103

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Change in SCORAD index
timeFrame: baseline and 6 weeks
Secondary outcomes:
measure: Changes in Th2 immunity
timeFrame: baseline and 6 weeks
measure: Change in dendritic cell-mediated tolerance and regulatory T cells
timeFrame: baseline and 6 weeks
measure: Effect of VD3 supplementation on immunity to Staphylococcus aureus
timeFrame: baseline and 6 weeks
measure: Vitamin D receptor single nucleotide polymorphisms
timeFrame: baseline and 6 weeks
measure: Change in epidermal protein expression
timeFrame: 6 weeks
Other outcomes:
measure: Number of participants with adverse events
timeFrame: 6 weeks
Locations:
city: Santiago
country: Chile
facility: School of Medicine, Pontificia Universidad Católica de Chile
Study officials:
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Arturo Borzutzky, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital, Harvard University, Boston, USA
name: Carlos A Camargo Jr., M.D., DrPH
role: STUDY_DIRECTOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Cristian Vera, M.D.
role: STUDY_DIRECTOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Lorena Cifuentes, M.D.
role: STUDY_DIRECTOR
affiliation: School of Medicine, Pontificia Universidad Católica de Chile
name: Sergio Silva, M.D.
role: STUDY_DIRECTOR
References: