ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Psoriasis vulgaris

Condition category

Condition code

Skin

Dermatological conditions

Diet and Nutrition

Other diet and nutrition disorders

Human Genetics and Inherited Disorders

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]

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]

Change in Psoriasis Area and Severity Index (PASI) scores in treatment group compared to placebo group.

Timepoint [1]

Baseline, 3 months, 6 months, 9 months and 12 months.

Primary outcome [2]

Change in serum 25(OH)D levels and PASI scores according to different vitamin D receptor genetic polymorphisms.

Timepoint [2]

Baseline, 3 months, 6 months, 9 months and 12 months.

Secondary outcome [1]

Quality of life as assessed using the Dermatology Life Quality Index questionnaire.

Timepoint [1]

Baseline, 3 months, 6 months, 9 months and 12 months.

Secondary outcome [2]

Change in inflammatory marker levels in the treatment group compared to the placebo group.

Timepoint [2]

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?

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Massey University

Address [1]

Private Bag 102904
North Shore
Auckland 0745

Country [1]

New Zealand

Funding source category [2]

Government body

Name [2]

Lottery Health Research

Address [2]

C/- Department of Internal Affairs
Level 7, 22 The Terrace
Wellington 6011

Country [2]

New Zealand

Primary sponsor type

University

Name

Massey University

Address

Private Bag 102904
North Shore
Auckland 0745

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee - Northern X Regional

Ethics committee address [1]

Private Bag 92522 Wellesley St, Auckland 1141

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

28/06/2011

Approval date [1]

16/01/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Michelle Ingram

Address

c/ Massey University
IFNHH
Private Bag 102 904
North Shore
Auckland 0745
New Zealand

Country

New Zealand

Phone

+64 9 414 0800 xtn 41173

Fax

m.ingram@massey.ac.nz

Contact person for scientific queries

Name

Dr Pamela von Hurst

Address

c/ Massey University
IFNHH
Private Bag 102 904
North Shore
Auckland 0745
New Zealand

Country

New Zealand

Phone

+64 9 414 0800 xtn 41205

Fax

P.R.vonHurst@massey.ac.nz

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

Source	Title	Year of Publication	DOI
Embase	Vitamin D Signaling in Psoriasis: Pathogenesis and Therapy.	2022	https://dx.doi.org/10.3390/ijms23158575

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically