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

NCT ID: NCT03257215

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-16
• Study Completion Date: 2025-01-30

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Stoss vitamin D

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

Group Type: ACTIVE_COMPARATOR

Stoss vitamin D

Intervention Type: DRUG

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. )

Daily placebo

Intervention Type: DRUG

A once daily 0.2 mL dose administered from Day 1 to 90

Daily vitamin D

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

Group Type: ACTIVE_COMPARATOR

Daily vitamin D

Intervention Type: DRUG

Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90

Stoss placebo

Intervention Type: DRUG

A single 1.5 mL dose administered on Day 1

Placebo

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

Group Type: PLACEBO_COMPARATOR

Stoss placebo

Intervention Type: DRUG

A single 1.5 mL dose administered on Day 1

Daily placebo

Intervention Type: DRUG

A once daily 0.2 mL dose administered from Day 1 to 90

Interventions

Stoss vitamin D

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. )

Intervention Type: DRUG

Daily vitamin D

Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90

Intervention Type: DRUG

Stoss placebo

A single 1.5 mL dose administered on Day 1

Intervention Type: DRUG

Daily placebo

A once daily 0.2 mL dose administered from Day 1 to 90

Intervention Type: DRUG

Other Intervention Names

Stoss cholecalciferol; Daily cholecalciferol (OsteVit D Liquid®); Oral Stoss Placebo (Olive Oil B.P.); Oral Daily Placebo (to match OsteVit D Liquid®)

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Murdoch Childrens Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirsten P Perrett, MBBS

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

Royal Children's Hospital Melbourne

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

HREC 36237

Identifier Type: -

Identifier Source: org_study_id