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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
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.
Trial website
https://clinicaltrials.gov/study/NCT03257215
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03257215