search
Back to results

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

Primary Purpose

Atopic Dermatitis

Status
Suspended
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Stoss vitamin D
Daily vitamin D
Stoss placebo
Daily placebo
Sponsored by
Murdoch Childrens Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Vitamin D

Eligibility Criteria

1 Year - 12 Years (Child)All SexesAccepts 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

Sites / Locations

  • Royal Children's Hospital Melbourne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Stoss vitamin D

Daily vitamin D

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in SCORAD
Atopic dermatitis severity score (SCORAD)

Secondary Outcome Measures

Vitamin D levels
vitamin D level in serum
Vitamin D polymorphisms
Presence of defined vitamin D polymorphisms
Immunoglobulin E (IgE) (serum)
Serum
Effects on Parameters of bone metabolism (serum)
Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase
Effects on Parameters of bone metabolism (urine)
Calcium:Creatinine (urine)
Quality of life (family)
Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI)
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
Compliance to study medications
Vitamin D stoss/daily and placebo stoss/daily
Adverse events
Serious adverse events and serious adverse events
SCORAD
Atopic dermatitis severity score (SCORAD)

Full Information

First Posted
August 13, 2017
Last Updated
February 7, 2023
Sponsor
Murdoch Childrens Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT03257215
Brief Title
Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? The D-Vex Pilot Study
Acronym
D-Vex
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Suspended
Why Stopped
Recruitment very slow & funding difficult - exacerbated by COVID-19 pandemic
Study Start Date
October 16, 2017 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Murdoch Childrens Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stoss vitamin D
Arm Type
Active Comparator
Arm Description
Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90)
Arm Title
Daily vitamin D
Arm Type
Active Comparator
Arm Description
Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)
Intervention Type
Drug
Intervention Name(s)
Stoss vitamin D
Other Intervention Name(s)
Stoss cholecalciferol
Intervention Description
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
Intervention Name(s)
Daily vitamin D
Other Intervention Name(s)
Daily cholecalciferol (OsteVit D Liquid®)
Intervention Description
Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90
Intervention Type
Drug
Intervention Name(s)
Stoss placebo
Other Intervention Name(s)
Oral Stoss Placebo (Olive Oil B.P.)
Intervention Description
A single 1.5 mL dose administered on Day 1
Intervention Type
Drug
Intervention Name(s)
Daily placebo
Other Intervention Name(s)
Oral Daily Placebo (to match OsteVit D Liquid®)
Intervention Description
A once daily 0.2 mL dose administered from Day 1 to 90
Primary Outcome Measure Information:
Title
Change in SCORAD
Description
Atopic dermatitis severity score (SCORAD)
Time Frame
Change from baseline at 3 months
Secondary Outcome Measure Information:
Title
Vitamin D levels
Description
vitamin D level in serum
Time Frame
Baseline and 3 months
Title
Vitamin D polymorphisms
Description
Presence of defined vitamin D polymorphisms
Time Frame
Baseline
Title
Immunoglobulin E (IgE) (serum)
Description
Serum
Time Frame
Baseline and 3 months
Title
Effects on Parameters of bone metabolism (serum)
Description
Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase
Time Frame
Baseline and 3 months
Title
Effects on Parameters of bone metabolism (urine)
Description
Calcium:Creatinine (urine)
Time Frame
Baseline, 1 month and 3 months
Title
Quality of life (family)
Description
Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI)
Time Frame
Baseline and 3 months
Title
Quality of life (child)
Description
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
Time Frame
Baseline and 3 months
Title
Compliance to study medications
Description
Vitamin D stoss/daily and placebo stoss/daily
Time Frame
Throughout the study period, , an average of 3 months
Title
Adverse events
Description
Serious adverse events and serious adverse events
Time Frame
Throughout the study period, an average of 3 months
Title
SCORAD
Description
Atopic dermatitis severity score (SCORAD)
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten P Perrett, MBBS
Organizational Affiliation
Murdoch Children's Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Children's Hospital Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs