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

NCT03257215 | Terminated Phase 4

• 1 other identifier: HREC 36237
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

Vitamin D

Outcome Measures

Primary Outcomes (1)

• Change in SCORAD

  Atopic dermatitis severity score (SCORAD)

  Change from baseline at 3 months

Secondary Outcomes (10)

• Vitamin D levels

  Baseline and 3 months

• Vitamin D polymorphisms

  Baseline

• Immunoglobulin E (IgE) (serum)

  Baseline and 3 months

• Effects on Parameters of bone metabolism (serum)

  Baseline and 3 months

• Effects on Parameters of bone metabolism (urine)

  Baseline, 1 month and 3 months

Study Arms (3)

Stoss vitamin D

ACTIVE COMPARATOR

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

Drug: Stoss vitamin D; Drug: Daily placebo

Daily vitamin D

ACTIVE COMPARATOR

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

Drug: Daily vitamin D; Drug: Stoss placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Stoss placebo; Drug: Daily placebo

Interventions

Stoss vitamin D 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. )

Also known as: Stoss cholecalciferol

Stoss vitamin D

Daily vitamin D DRUG

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

Also known as: Daily cholecalciferol (OsteVit D Liquid®)

Daily vitamin D

Stoss placebo DRUG

A single 1.5 mL dose administered on Day 1

Also known as: Oral Stoss Placebo (Olive Oil B.P.)

Daily vitamin D; Placebo

Daily placebo DRUG

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

Also known as: Oral Daily Placebo (to match OsteVit D Liquid®)

Placebo; Stoss vitamin D

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Royal Children's Hospital Melbourne

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kirsten P Perrett, MBBS

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2017
• First Posted: August 22, 2017
• Study Start: October 16, 2017
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

AU (1)