Vitamin D is known to have a regulatory influence on both the immune system and skin barrier function. Studies in paediatric populations have found an inverse association of vitamin D levels and with both prevalence and severity of atopic dermatitis (AD). Trials of vitamin D as a treatment for AD are limited in number and size. There has never been a placebo-controlled randomised controlled trial of stoss high dose versus daily standard dose for the treatment of AD. Further, no trials have explored the presence of vitamin D pathway genes and response to treatment of AD. This pilot study will be used as a reference to determine outcomes and feasibility for undertaking a larger and more in depth definitive study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
A single 1.5 mL dose containing 150,000 IU cholecalciferol (100,000 IU/mL) administered on Day 1 (Solution in Olive Oil B.P. )
Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90
A single 1.5 mL dose administered on Day 1
A once daily 0.2 mL dose administered from Day 1 to 90
Royal Children's Hospital Melbourne
Melbourne, Victoria, Australia
Change in SCORAD
Atopic dermatitis severity score (SCORAD)
Time frame: Change from baseline at 3 months
Vitamin D levels
vitamin D level in serum
Time frame: Baseline and 3 months
Vitamin D polymorphisms
Presence of defined vitamin D polymorphisms
Time frame: Baseline
Immunoglobulin E (IgE) (serum)
Serum
Time frame: Baseline and 3 months
Effects on Parameters of bone metabolism (serum)
Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase
Time frame: Baseline and 3 months
Effects on Parameters of bone metabolism (urine)
Calcium:Creatinine (urine)
Time frame: Baseline, 1 month and 3 months
Quality of life (family)
Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI)
Time frame: Baseline and 3 months
Quality of life (child)
Standardised questionnaire: Child Dermatology Life Quality Index (CDLQI) if \>= 4 years of age OR Infant Dermatology Quality of Life (IDQOL) if \<4 years of age
Time frame: Baseline and 3 months
Compliance to study medications
Vitamin D stoss/daily and placebo stoss/daily
Time frame: Throughout the study period, , an average of 3 months
Adverse events
Serious adverse events and serious adverse events
Time frame: Throughout the study period, an average of 3 months
SCORAD
Atopic dermatitis severity score (SCORAD)
Time frame: At 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.