Atopic Dermatitis
Conditions
Keywords
Vitamin D
Brief summary
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.
Interventions
DRUGStoss vitamin D
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. )
DRUGDaily vitamin D
Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90
DRUGStoss placebo
A single 1.5 mL dose administered on Day 1
DRUGDaily placebo
A once daily 0.2 mL dose administered from Day 1 to 90
Sponsors
Murdoch Childrens Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* moderate to severe atopic dermatitis with a SCORAD ≥ 20 at baseline. * aged between 1 ≤ 12 years of age at the time of randomisation. * regularly ingest the recommended dietary intake (RDI) of calcium and plan to do so for the next 3 months * have a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Exclusion criteria
* use of vitamin D supplementation, including a stoss dose of vitamin D in the previous year, or daily supplementation in the past month * drink vitamin D fortified formula (all formulas) as the main milk intake * received oral steroids within the past 6 months * received oral immunosuppression in the past (cyclosporine, azathioprine, methotrexate) * received UV therapy in the past 12 months * have been fully formula fed within the past 6 months * ave renal or liver or gastrointestinal (e.g.: coeliac, inflammatory bowel disease) disease * receiving thiazide-type diuretics or anticonvulsant therapy * have ever been diagnosed with Hypercalcaemia, Hypertension or Rickets * unable to provide consent without the aid of an interpreter * in the opinion of the Investigator, are unable to follow the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in SCORAD | Change from baseline at 3 months | Atopic dermatitis severity score (SCORAD) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin D polymorphisms | Baseline | Presence of defined vitamin D polymorphisms |
| Immunoglobulin E (IgE) (serum) | Baseline and 3 months | Serum |
| Effects on Parameters of bone metabolism (serum) | Baseline and 3 months | Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase |
| Effects on Parameters of bone metabolism (urine) | Baseline, 1 month and 3 months | Calcium:Creatinine (urine) |
| Vitamin D levels | Baseline and 3 months | vitamin D level in serum |
| Quality of life (child) | Baseline and 3 months | 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 |
| Compliance to study medications | Throughout the study period, , an average of 3 months | Vitamin D stoss/daily and placebo stoss/daily |
| Adverse events | Throughout the study period, an average of 3 months | Serious adverse events and serious adverse events |
| SCORAD | At 3 months | Atopic dermatitis severity score (SCORAD) |
| Quality of life (family) | Baseline and 3 months | Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI) |
Countries
Australia
Outcome results
None listed