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

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

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.

Study Overview

• Status: Suspended
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Stoss vitamin D; Drug: Daily placebo; Drug: Daily vitamin D; Drug: Stoss placebo

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3052
      • Royal Children's Hospital Melbourne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Murdoch Childrens Research Institute
• Investigators: Principal Investigator: Kirsten P Perrett, MBBS, Murdoch Children's Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2017
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 13, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Vitamin D
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: HREC 36237

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No