Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03257215




Registration number
NCT03257215
Ethics application status
Date submitted
13/08/2017
Date registered
22/08/2017
Date last updated
27/09/2024

Titles & IDs
Public title
Can Vitamin D Treatment Help Treat Moderate to Severe Atopic Dermatitis in Young Children? the D-Vex Pilot Study
Scientific 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
Secondary ID [1] 0 0
HREC 36237
Universal Trial Number (UTN)
Trial acronym
D-Vex
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Stoss vitamin D
Treatment: Drugs - Daily vitamin D
Treatment: Drugs - Stoss placebo
Treatment: Drugs - Daily placebo

Active comparator: Stoss vitamin D - Stoss vitamin D at Day 1 and daily placebo for 90 days (Day 1 to 90)

Active comparator: Daily vitamin D - Stoss placebo at Day 1 and daily vitamin D for 90 days (Day 1 to 90)

Placebo comparator: Placebo - Stoss placebo at Day 1 and daily placebo for 90 days (Day 1 to 90)


Treatment: Drugs: 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. )

Treatment: Drugs: Daily vitamin D
Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90

Treatment: Drugs: Stoss placebo
A single 1.5 mL dose administered on Day 1

Treatment: Drugs: Daily placebo
A once daily 0.2 mL dose administered from Day 1 to 90
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in SCORAD
Timepoint [1] 0 0
Change from baseline at 3 months
Secondary outcome [1] 0 0
Vitamin D levels
Timepoint [1] 0 0
Baseline and 3 months
Secondary outcome [2] 0 0
Vitamin D polymorphisms
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Immunoglobulin E (IgE) (serum)
Timepoint [3] 0 0
Baseline and 3 months
Secondary outcome [4] 0 0
Effects on Parameters of bone metabolism (serum)
Timepoint [4] 0 0
Baseline and 3 months
Secondary outcome [5] 0 0
Effects on Parameters of bone metabolism (urine)
Timepoint [5] 0 0
Baseline, 1 month and 3 months
Secondary outcome [6] 0 0
Quality of life (family)
Timepoint [6] 0 0
Baseline and 3 months
Secondary outcome [7] 0 0
Quality of life (child)
Timepoint [7] 0 0
Baseline and 3 months
Secondary outcome [8] 0 0
Compliance to study medications
Timepoint [8] 0 0
Throughout the study period, , an average of 3 months
Secondary outcome [9] 0 0
Adverse events
Timepoint [9] 0 0
Throughout the study period, an average of 3 months
Secondary outcome [10] 0 0
SCORAD
Timepoint [10] 0 0
At 3 months

Eligibility
Key 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.
Minimum age
1 Year
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Children's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kirsten P Perrett, MBBS
Address 0 0
Murdoch Children's Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03257215