Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? The D-Vex Pilot Study
- Conditions
- Atopic Dermatitis
- Interventions
- Registration Number
- NCT03257215
- Lead Sponsor
- Murdoch Childrens Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
- 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) 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Stoss vitamin D Stoss vitamin D Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90) Stoss vitamin D Daily placebo Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90) Daily vitamin D Daily vitamin D Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90) Placebo Stoss placebo Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90) Daily vitamin D Stoss placebo Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90) Placebo Daily placebo Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)
- Primary Outcome Measures
Name Time Method Change in SCORAD Change from baseline at 3 months Atopic dermatitis severity score (SCORAD)
- Secondary Outcome Measures
Name Time Method Effects on Parameters of bone metabolism (urine) Baseline, 1 month and 3 months Calcium:Creatinine (urine)
Quality of life (family) Baseline and 3 months Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI)
Adverse events Throughout the study period, an average of 3 months Serious adverse events and serious adverse events
Effects on Parameters of bone metabolism (serum) Baseline and 3 months Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase
Immunoglobulin E (IgE) (serum) Baseline and 3 months 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
Vitamin D polymorphisms Baseline Presence of defined vitamin D polymorphisms
SCORAD At 3 months Atopic dermatitis severity score (SCORAD)
Vitamin D levels Baseline and 3 months vitamin D level in serum
Trial Locations
- Locations (1)
Royal Children's Hospital Melbourne
🇦🇺Melbourne, Victoria, Australia