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

March 11, 2025 updated by: Murdoch Childrens Research Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in SCORAD
Time Frame: Change from baseline at 3 months
Atopic dermatitis severity score (SCORAD)
Change from baseline at 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vitamin D levels
Time Frame: Baseline and 3 months
vitamin D level in serum
Baseline and 3 months
Vitamin D polymorphisms
Time Frame: Baseline
Presence of defined vitamin D polymorphisms
Baseline
Immunoglobulin E (IgE) (serum)
Time Frame: Baseline and 3 months
Serum
Baseline and 3 months
Effects on Parameters of bone metabolism (serum)
Time Frame: Baseline and 3 months
Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase
Baseline and 3 months
Effects on Parameters of bone metabolism (urine)
Time Frame: Baseline, 1 month and 3 months
Calcium:Creatinine (urine)
Baseline, 1 month and 3 months
Quality of life (family)
Time Frame: Baseline and 3 months
Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI)
Baseline and 3 months
Quality of life (child)
Time Frame: Baseline and 3 months
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
Time Frame: Throughout the study period, , an average of 3 months
Vitamin D stoss/daily and placebo stoss/daily
Throughout the study period, , an average of 3 months
Adverse events
Time Frame: Throughout the study period, an average of 3 months
Serious adverse events and serious adverse events
Throughout the study period, an average of 3 months
SCORAD
Time Frame: At 3 months
Atopic dermatitis severity score (SCORAD)
At 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Murdoch Childrens Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kirsten P Perrett, MBBS, Murdoch Children's Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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