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Atopic DermatitisPhase 4D-VexNCT03257215

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

A Phase 4 study testing Stoss vitamin D and Daily vitamin D in people with Atopic Dermatitis, run by Murdoch Childrens Research Institute at 1 site in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 1 year to 12 yearsHealthy volunteers can take part
Conditions the study is for
Atopic Dermatitis
What is being tested?
Stoss vitamin D and Daily vitamin D
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
1 siteAustralia
Study dates
16 Oct 2017to 30 Jan 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Royal Children's Hospital Melbourne

    Melbourne, Victoria, 3052

Other trials in Australia

About this study

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

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.

Being tested
Stoss vitamin D, Daily vitamin D, Stoss placebo, Daily placebo
Keywords
Vitamin D
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stoss vitamin DDrug

    Also called Stoss cholecalciferol

    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 vitamin DDrug

    Also called Daily cholecalciferol (OsteVit D Liquid®)

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

  • Stoss placeboDrug

    Also called Oral Stoss Placebo (Olive Oil B.P.)

    A single 1.5 mL dose administered on Day 1

  • Daily placeboDrug

    Also called Oral Daily Placebo (to match OsteVit D Liquid®)

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

Study groups in NCT03257215
Study groupRoleWhat they receive
Stoss vitamin DActive comparatorStoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90)
Receives: Drug: Stoss vitamin D; Drug: Daily placebo
Daily vitamin DActive comparatorStoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90)
Receives: Drug: Daily vitamin D; Drug: Stoss placebo
PlaceboPlacebo comparatorStoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)
Receives: Drug: Stoss placebo; Drug: Daily placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in SCORAD

    Atopic dermatitis severity score (SCORAD)

    Measured: Change from baseline at 3 months

Secondary outcomes (10)

  1. Vitamin D levels

    vitamin D level in serum

    Measured: Baseline and 3 months

  2. Vitamin D polymorphisms

    Presence of defined vitamin D polymorphisms

    Measured: Baseline

  3. Immunoglobulin E (IgE) (serum)

    Serum

    Measured: Baseline and 3 months

  4. Effects on Parameters of bone metabolism (serum)

    Calcium, Phosphate, Parathyroid hormone, Alkaline Phosphatase

    Measured: Baseline and 3 months

  5. Effects on Parameters of bone metabolism (urine)

    Calcium:Creatinine (urine)

    Measured: Baseline, 1 month and 3 months

  6. Quality of life (family)

    Standardised questionnaire: Family Dermatology Life Quality Index (FDLQI)

    Measured: Baseline and 3 months

  7. 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

    Measured: Baseline and 3 months

  8. Compliance to study medications

    Vitamin D stoss/daily and placebo stoss/daily

    Measured: Throughout the study period, , an average of 3 months

  9. Adverse events

    Serious adverse events and serious adverse events

    Measured: Throughout the study period, an average of 3 months

  10. SCORAD

    Atopic dermatitis severity score (SCORAD)

    Measured: At 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2017
  2. Study start16 Oct 2017
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2025

Why it stopped: Recruitment very slow \& ongoing funding not obtained.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03257215
Sponsor's protocol ID
HREC 36237
Acronym
D-Vex
Status last verified
Mar 2025
First submitted
13 Aug 2017
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Stoss vitamin D and Daily vitamin D in people with Atopic Dermatitis, run by Murdoch Childrens Research Institute at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment very slow \& ongoing funding not obtained.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in SCORAD (time frame: Change from baseline at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03257215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.

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