Trial Review

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 registered on ANZCTR


Registration number
ACTRN12611000648921
Ethics application status
Approved
Date submitted
22/06/2011
Date registered
24/06/2011
Date last updated
23/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Vitamin D and Psoriasis Study
Scientific title
In patients with psoriasis vulgaris, can supplementation with vitamin D3 improve psoriasis as measured by Psoriasis Area and Severity Index score?
Secondary ID [1] 262431 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis vulgaris 268121 0
Condition category
Condition code
Skin 268269 268269 0 0
Dermatological conditions
Diet and Nutrition 268270 268270 0 0
Other diet and nutrition disorders
Human Genetics and Inherited Disorders 268271 268271 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
200,000 IU of vitamin D3 in capsule form at baseline, then 1 x 100,000 IU per month for the next 11 months.
Intervention code [1] 266805 0
Treatment: Other
Comparator / control treatment
Inactive placebo capsule, identical in taste and appearance to treatment but with no vitamin D3. Two capsules at baseline then then one capsule per month for the next 11 months.
Control group
Placebo

Outcomes
Primary outcome [1] 268994 0
Change in Psoriasis Area and Severity Index (PASI) scores in treatment group compared to placebo group.
Timepoint [1] 268994 0
Baseline, 3 months, 6 months, 9 months and 12 months.
Primary outcome [2] 268995 0
Change in serum 25(OH)D levels and PASI scores according to different vitamin D receptor genetic polymorphisms.
Timepoint [2] 268995 0
Baseline, 3 months, 6 months, 9 months and 12 months.
Secondary outcome [1] 276771 0
Quality of life as assessed using the Dermatology Life Quality Index questionnaire.
Timepoint [1] 276771 0
Baseline, 3 months, 6 months, 9 months and 12 months.
Secondary outcome [2] 276772 0
Change in inflammatory marker levels in the treatment group compared to the placebo group.
Timepoint [2] 276772 0
Baseline, 3 months, 6 months, 9 months and 12 months.

Eligibility
Key inclusion criteria
Medically diagnosed psoriasis vulgaris
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smoking; chronic kidney or liver disease; currently taking vitamin D supplements, or have taken them within the past two months; pregnant or lactating, or planning to be in the near future; have commenced a new psoriasis treatment within the past three months and wish to continue

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3638 0
New Zealand
State/province [1] 3638 0

Funding & Sponsors
Funding source category [1] 267279 0
University
Name [1] 267279 0
Massey University
Country [1] 267279 0
New Zealand
Funding source category [2] 285305 0
Government body
Name [2] 285305 0
Lottery Health Research
Country [2] 285305 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Private Bag 102904
North Shore
Auckland 0745
Country
New Zealand
Secondary sponsor category [1] 266339 0
None
Name [1] 266339 0
Address [1] 266339 0
Country [1] 266339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269274 0
Health and Disability Ethics Committee - Northern X Regional
Ethics committee address [1] 269274 0
Private Bag 92522 Wellesley St, Auckland 1141
Ethics committee country [1] 269274 0
New Zealand
Date submitted for ethics approval [1] 269274 0
28/06/2011
Approval date [1] 269274 0
16/01/2012
Ethics approval number [1] 269274 0

Summary
Brief summary
Psoriasis is a common, non-infectious inflammatory disease of the skin for which there is no known cure. This condition can have a profound negative effect on quality of life, both physically and psychologically. All existing treatments have significant drawbacks, including increased risk of infection and cancers. Many of the known functions of vitamin D oppose the symptoms of psoriasis, including reducing inflammation, cell overgrowth and immune response. In addition, vitamin D is the most likely therapeutic agent in some topical creams and UVB light therapy. We propose that supplementation of vitamin D in psoriasis patients will increase and maintain vitamin D levels and consequently reduce psoriasis symptoms in a similar manner to UVB and topical treatments, but without the risks, side effects or inconvenience. One hundred men and women with psoriasis will be recruited for a randomised, double-blind, placebo-controlled trial. Subjects will be matched for severity and randomised into active and placebo groups. They will attend five appointments over a one year period, during which they will take vitamin D or placebo, and be assessed for vitamin D status, levels of other relevant biomarkers, change in extent of psoriasis, body composition, and quality of life. We will also investigate whether there are any interactions between different vitamin D receptor genes and response to vitamin D. It is hypothesised that those taking vitamin D will show an improvement in psoriasis alongside an increase in vitamin D levels compared to those on the placebo, and that there will be a relationship between at least one vitamin D receptor genetic variation and response to vitamin D.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32765 0
Address 32765 0
Country 32765 0
Phone 32765 0
Fax 32765 0
Email 32765 0
Contact person for public queries
Name 16012 0
Michelle Ingram
Address 16012 0
c/ Massey University
IFNHH
Private Bag 102 904
North Shore
Auckland 0745
New Zealand
Country 16012 0
New Zealand
Phone 16012 0
+64 9 414 0800 xtn 41173
Fax 16012 0
Email 16012 0
[email protected]
Contact person for scientific queries
Name 6940 0
Dr Pamela von Hurst
Address 6940 0
c/ Massey University
IFNHH
Private Bag 102 904
North Shore
Auckland 0745
New Zealand
Country 6940 0
New Zealand
Phone 6940 0
+64 9 414 0800 xtn 41205
Fax 6940 0
Email 6940 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseVitamin D Signaling in Psoriasis: Pathogenesis and Therapy.2022https://dx.doi.org/10.3390/ijms23158575
N.B. These documents automatically identified may not have been verified by the study sponsor.