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Trial registered on ANZCTR


Registration number
ACTRN12612000570886
Ethics application status
Approved
Date submitted
28/05/2012
Date registered
28/05/2012
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin D in the management of Childhood Atopic Dermatitis (eczema)
Scientific title
In children aged 2-16 with moderate to severe atopic dermatitis (eczema), is daily vitamin D3 (1000 IU/day) more effective than placebo in improving the severity of the eczema and quality of life.
Secondary ID [1] 280561 0
nil
Universal Trial Number (UTN)
U1111-1131-2345
Trial acronym
ADDVIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 286564 0
Condition category
Condition code
Inflammatory and Immune System 286833 286833 0 0
Allergies
Skin 286837 286837 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible children recruited and enrolled will be randomised to receive either liquid drops of Vitamin D 3 (Cholecalciferol)(1000 IU/day) or placebo for a period of 3 months. All children enrolled will be allowed to continue their normal skin care regime, with use of moisturisers and topical steroids throughout the study period.
Intervention code [1] 284946 0
Treatment: Drugs
Comparator / control treatment
placebo- liquid vehicle with no Vitamin D3

All children enrolled will be allowed to continue their normal skin care regime, with use of moisturisers and topical steroids throughout the study period.
Control group
Placebo

Outcomes
Primary outcome [1] 287194 0
Eczema severity score (SCORAD)
Timepoint [1] 287194 0
t=0, t=1.5 and t=3 (0, 6 weeks and 3 months)
Secondary outcome [1] 297595 0
Use of topical steroid (frequency, potency)
By specially designed parent daily recording diary.
Timepoint [1] 297595 0
t=0, t=1.5 and t=3 (0, 6 weeks and 3 months)
Secondary outcome [2] 297600 0
Quality of life (QoL),
By previously published quality of life in eczema in childhood and eczema in infants questionaires. Parents fill in the infant questionaire. the child questionaire is designed for children aged >4 to complete.
Timepoint [2] 297600 0
t=0, t=1.5 and t=3 (0, 6 weeks and 3 months)
Secondary outcome [3] 297601 0
Treg phenotype
T cells are phenotyped by colour flow cytometry and analuyed by FACS.
T reg cell function is detremined by in vitro cellular supression culture assay
Timepoint [3] 297601 0
t=0, t=3 months
Secondary outcome [4] 297602 0
Vitamin D status
By laboratory measurement of Vitamin D level in serum
Timepoint [4] 297602 0
t=0, t=3 months

Eligibility
Key inclusion criteria
Inclusion criteria-
Atopic dermatitis consistent with diagnostic criteria of Hanifin and Rajka.
Ages- 2 years- 16 years
Moderate-severe eczema at study entry defined as an objective SCORAD of > 15 (0-83)
Minimum age
2 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
Ages <2 years or >16 years
Past or current history of oral immunosuppression therapy (Cyclosporin, Azathioprine, Methotrexate)
Oral corticosteroids < 6 months prior to study
IVIg therapy< 2 years prior to study
Hypercalcaemia, Hypertension, Anticonvulsant therapy

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)
Children will randomly allocated in a 1:1 ratio to "Vit D" and "Placebo" treatments. Treatment allocation will stratified by gender.
Numbered containers with central randomisation by computer with code held by one designated person not involved with any other aspects of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation used permuted blocks to maintain treatment balance over time, and blocks will be a random mixture of sizes to assist allocation concealment
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2012
Actual
11/03/2013
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
36
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11476 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 23497 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 285326 0
Hospital
Name [1] 285326 0
Department of Allergy and Immunology, Childrens Hospital Westmead
Country [1] 285326 0
Australia
Primary sponsor type
Individual
Name
Prof Dianne Campbell
Address
Childrens Hospital Westemad
Hawkesbury rd
Westmead
NSW 2145
Country
Australia
Secondary sponsor category [1] 284180 0
Individual
Name [1] 284180 0
Professor Ralph Nanan
Address [1] 284180 0
Nepean clinical School
Nepean Hospital
Derby St, Kingswood, NSW 2747
Country [1] 284180 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287342 0
Sydney Childrens Hopsitals Network HREC
Ethics committee address [1] 287342 0
Hawkesbury Rd
CHW
Westmead
NSW 2145
Ethics committee country [1] 287342 0
Australia
Date submitted for ethics approval [1] 287342 0
02/03/2012
Approval date [1] 287342 0
14/11/2012
Ethics approval number [1] 287342 0
12/SCHN/24

Summary
Brief summary
The project aims to show that oral vitamin D supplementation will improve the severity of childhood atopic dermatitis (eczema). We will compare the severity of disease in children with moderate-severe atopic dermatitis after 3 months of daily Vitamin D therapy or placebo, using randomised double blind placebo controlled methodology.
We propose that the severity of moderate and moderate-severe atopic dermatitis will be significantly decreased by oral Vitamin D therapy. We aim to show that in these children, following 3 months of daily vitamin D3 at 1000IU, there will be a significant decrease in their disease severity and decreased use of topical corticosteroids. We aim to demonstrate a significant improvement in the quality of life for these children, as measured by a validated quality of life questionnaire.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34229 0
Prof Dianne E Campbell
Address 34229 0
Department of Allergy and Immunology
Locked Bag 4001
Children's Hospital Westmead, Sydney
NSW 2145
Country 34229 0
Australia
Phone 34229 0
+61298453420
Fax 34229 0
Email 34229 0
[email protected]
Contact person for public queries
Name 17476 0
Prof Dianne Campbell
Address 17476 0
Department of Allergy and Immunology
CHW, Hawkesbury Rd
Westmead
NSW
2145
Country 17476 0
Australia
Phone 17476 0
+61298453420
Fax 17476 0
+61298453389
Email 17476 0
[email protected]
Contact person for scientific queries
Name 8404 0
Prof Dianne Campbell
Address 8404 0
Department of Allergy and Immunology
CHW,Hawkesbury Rd
Westmead
NSW
2145
Country 8404 0
Australia
Phone 8404 0
+61298453420
Fax 8404 0
+61298453389
Email 8404 0
[email protected]

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

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