Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? the D-Vex Pilot Study

A Phase IV, Double-blind, Randomised, Placebo-controlled Trial to Assess the Efficacy and Safety of Stoss Versus Daily Dose Oral Vitamin D Compared to Placebo for the Treatment of Atopic Dermatitis in Pre-school Aged Children- a Pilot Study

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.

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