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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.
1 Year to 12 Years
Accepts Healthy Volunteers
– 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.
– 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)
– 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
Murdoch Childrens Research Institute
Principal Investigator: Kirsten P Perrett, MBBS
Murdoch Children's Research Institute
Please refer to this study by its ClinicalTrials.gov identifier: NCT03257215