Clinical trial NCT03257215: Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? the D-Vex Pilot Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Atopic Dermatitis
Keywords: Vitamin D
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 13
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in SCORAD
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Vitamin D levels
timeFrame: Baseline and 3 months
measure: Vitamin D polymorphisms
timeFrame: Baseline
measure: Immunoglobulin E (IgE) (serum)
timeFrame: Baseline and 3 months
measure: Effects on Parameters of bone metabolism (serum)
timeFrame: Baseline and 3 months
measure: Effects on Parameters of bone metabolism (urine)
timeFrame: Baseline, 1 month and 3 months
measure: Quality of life (family)
timeFrame: Baseline and 3 months
measure: Quality of life (child)
timeFrame: Baseline and 3 months
measure: Compliance to study medications
timeFrame: Throughout the study period, , an average of 3 months
measure: Adverse events
timeFrame: Throughout the study period, an average of 3 months
measure: SCORAD
timeFrame: At 3 months
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Children's Hospital Melbourne
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Kirsten P Perrett, MBBS
role: PRINCIPAL_INVESTIGATOR
References: