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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Stoss vitamin D
* Drug: Daily vitamin D
* Drug: Stoss placebo
* Drug: Daily placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stoss vitamin D<br>Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90) | Drug: Stoss vitamin D<br>* 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. )<br>* Other names: Stoss cholecalciferol;Drug: Daily placebo<br>* A once daily 0.2 mL dose administered from Day 1 to 90<br>* Other names: Oral Daily Placebo (to match OsteVit D Liquid®);|
| Active Comparator: Daily vitamin D<br>Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90) | Drug: Daily vitamin D<br>* Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90<br>* Other names: Daily cholecalciferol (OsteVit D Liquid®);Drug: Stoss placebo<br>* A single 1.5 mL dose administered on Day 1<br>* Other names: Oral Stoss Placebo (Olive Oil B.P.);|
| Placebo Comparator: Placebo<br>Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90) | Drug: Stoss placebo<br>* A single 1.5 mL dose administered on Day 1<br>* Other names: Oral Stoss Placebo (Olive Oil B.P.);Drug: Daily placebo<br>* A once daily 0.2 mL dose administered from Day 1 to 90<br>* Other names: Oral Daily Placebo (to match OsteVit D Liquid®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SCORAD | Atopic dermatitis severity score (SCORAD) | Change from baseline at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels | vitamin D level in serum | Baseline and 3 months | 
| Vitamin D polymorphisms | Presence of defined vitamin D polymorphisms | Baseline | 
| Immunoglobulin E (IgE) (serum) | Serum | Baseline and 3 months | 
| Effects on Parameters of bone metabolism (serum) | Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase | Baseline and 3 months | 
| Effects on Parameters of bone metabolism (urine) | Calcium:Creatinine (urine) | Baseline, 1 month and 3 months | 
| Quality of life (family) | Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI) | 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 | Baseline and 3 months | 
| Compliance to study medications | Vitamin D stoss/daily and placebo stoss/daily | Throughout the study period, , an average of 3 months | 
| Adverse events | Serious adverse events and serious adverse events | Throughout the study period, an average of 3 months | 
| SCORAD | Atopic dermatitis severity score (SCORAD) | At 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D