Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000021471
Ethics application status
Approved
Date submitted
29/05/2006
Date registered
11/01/2007
Date last updated
8/11/2018
Date data sharing statement initially provided
8/11/2018
Date results information initially provided
8/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Ultraviolet Radiation on Blood Pressure, Cardiac Function and Insulin Sensitivity
Scientific title
A randomised phase III study to evaluate whether Ultraviolet Radiation B lowers blood pressure and insulin resistance and improves cardiac function in people with low vitamin D levels
Secondary ID [1] 296556 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with low vitamin D levels 1522 0
Condition category
Condition code
Cardiovascular 1620 1620 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised double-blind clinical trial comparing ultraviolet B radiation (treatment) with ultraviolet A radiation (control), given twice weekly for 12 weeks. UVB will start at 400mJ/cm2 (with 20% increments) in the Pacific participants, and start at 200 mJ/cm2 (with 5% increments) in the European participants. UVA treatments will start with 1 J/cm2 the first week (with 1 J/cm2 weekly increases to 6 J/cm2 and maintained) in Pacific participants, and start at 0.5 J/cm2 (with 0.5 J/cm2 weekly increases up to 3 J/cm2 and maintained) in European participants. UVB increases vitamin D (in contrast with UVA which is the control).
Intervention code [1] 1075 0
Prevention
Comparator / control treatment
UVA treatments will start with 1 J/cm2 the first week (with 1 J/cm2 weekly increases to 6 J/cm2 and maintained) in Pacific participants, and start at 0.5 J/cm2 (with 0.5 J/cm2 weekly increases up to 3 J/cm2 and maintained) in European participants.
Control group
Placebo

Outcomes
Primary outcome [1] 2233 0
Blood pressure
Timepoint [1] 2233 0
Measured at baseline and 12 weeks.
Secondary outcome [1] 3897 0
Insulin resistance (estimated from fasting insulin and triglycerides).
Timepoint [1] 3897 0
Baseline and 12 weeks
Secondary outcome [2] 3898 0
Cardiac function measured by Magnetic Resonance Imaging scan
Timepoint [2] 3898 0
At baseline and 12 weeks

Eligibility
Key inclusion criteria
Age - Pacific Island and Maori >50years, European >65years; 25OHD levels < 50 nmol/L.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypertension treated with thiazide diuretics, diabetes treated with insulin or oral hypoglycaemics, taking vitamin D supplements (including cod liver oil), planned travel to areas with high sun exposure during the study period.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation of allocation to ultraviolet radiation B (UVB) or ultraviolet radiation A (UVA), in sealed envelopes used in consecutive order
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation by computer software, within variable size blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2006
Actual
20/05/2006
Date of last participant enrolment
Anticipated
Actual
27/07/2007
Date of last data collection
Anticipated
Actual
25/10/2007
Sample size
Target
120
Accrual to date
Final
119
Recruitment outside Australia
Country [1] 321 0
New Zealand
State/province [1] 321 0

Funding & Sponsors
Funding source category [1] 1767 0
Government body
Name [1] 1767 0
Health Research Council of NZ
Country [1] 1767 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
Physical Address Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street, Auckland 1010
Postal Address PO Box 5541, Wellesley Street, Auckland 1141
Phone 09 303 5200
Fax 09 377 9988
Country
New Zealand
Secondary sponsor category [1] 1572 0
University
Name [1] 1572 0
University of Auckland
Address [1] 1572 0
Faculty of Medical & Health Sciences,
University off Auckland,
Private Bag 92019,
Auckland Mail Centre 1142,
Auckland
Country [1] 1572 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3298 0
Northern X Regional Ethics Committee
Ethics committee address [1] 3298 0
Ethics committee country [1] 3298 0
New Zealand
Date submitted for ethics approval [1] 3298 0
Approval date [1] 3298 0
27/02/2006
Ethics approval number [1] 3298 0
NTX/05/12/170

Summary
Brief summary
The study hypothesis is that UVB, which increases body levels of vitamin D, when given to vitamin D deficient people in winter when the sun is weak, will lower blood pressure and insulin resistance, and improve cardiac function, compared with UVA which has no effect on vitamin D synthesis.
All participants, both interviewers and myself will be blind to intervention. The UV is given by a nurse at a private dermatology clinic. She, the dermatologist at the clinic and the 3 members of an independent data monitoring committee, are the only people who know the allocation of the UV; plus a data entry person working for the data entry committee who keeps the baseline and follow-up bood results and who has no contact with participants.
Trial website
Trial related presentations / publications
Scragg R, Wishart J, Stewart A, Ofanoa M, Kerse N, Dyall L, Lawes CMM. No effect of ultraviolet radiation on blood pressure and other cardiovascular risk factors. J Hypertens 2011; 29: 1749-56.

McKenzie R, Scragg R, Liley B, Johnston P, Wishart J, Stewart A, Prematunga R. Serum 25-hydroxyvitamin-D responses to multiple UV exposures from solaria: inferences for exposure to sunlight. Photochem Photobiol Sci 2012; 11: 1174–1185
Public notes

Contacts
Principal investigator
Name 36299 0
Prof Robert Scragg
Address 36299 0
School of Population Health,
University of Auckland, Tamaki Campus,
Private Bag 92019,
Auckland Mail Centre 1142,
New Zealand
Country 36299 0
New Zealand
Phone 36299 0
+64-9-3737999
Fax 36299 0
Email 36299 0
[email protected]
Contact person for public queries
Name 10264 0
Prof Robert Scragg
Address 10264 0
Epidemiology and Biostatistics
School of Population Health
University of Auckland
Private Bag 92019
Auckland
Country 10264 0
New Zealand
Phone 10264 0
+64 9 3737599 ext. 86336
Fax 10264 0
Email 10264 0
[email protected]
Contact person for scientific queries
Name 1192 0
Prof Robert Scragg
Address 1192 0
Epidemiology and Biostatistics
School of Population Health
University of Auckland
Private Bag 92019
Auckland
Country 1192 0
New Zealand
Phone 1192 0
+64 9 3737599 ext. 86336
Fax 1192 0
Email 1192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.