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

Murdoch Childrens Research Institute

Status and phase: Terminated; Phase 4

Conditions: Atopic Dermatitis

Treatments: Drug: Daily placebo; Drug: Stoss placebo; Drug: Daily vitamin D; Drug: Stoss vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT03257215

HREC 36237

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 1 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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13 participants in 3 patient groups, including a placebo group

Stoss vitamin D

Active Comparator group

Description:

Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90)

Treatment:

Drug: Stoss vitamin D

Drug: Daily placebo

Daily vitamin D

Active Comparator group

Description:

Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90)

Treatment:

Drug: Daily vitamin D

Drug: Stoss placebo

Placebo

Placebo Comparator group

Description:

Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)

Treatment:

Drug: Stoss placebo

Drug: Daily placebo