Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001014246
Ethics application status
Not yet submitted
Date submitted
11/11/2009
Date registered
23/11/2009
Date last updated
23/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of acute pain after shingles with vitamin D cream
Scientific title
Treatment of acute herpes zoster neuralgia with high potency vitamin D cream
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute herpes zoster (shingles) 252170 0
Herpes zoster 252252 0
Condition category
Condition code
Infection 252372 252372 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a topical high potency vitamin D cream (20,000IU/g).
a. Dose 20,000IU
b. Twice a day
c. Until pain resolves or for up to 4 weeks
Intervention code [1] 241536 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253247 0
Relief of pain measured using a visual analogue scale
Timepoint [1] 253247 0
Days 1,7,14, 21 and 28 of treatment
Secondary outcome [1] 262208 0
Nil
Timepoint [1] 262208 0
Nil

Eligibility
Key inclusion criteria
Age 18-80
Adults with acute herpetic neuralgia
Able to provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to apply vitamin D cream
Skin condition or skin allergy so unable to use cream
Unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 2323 0
New Zealand
State/province [1] 2323 0

Funding & Sponsors
Funding source category [1] 244006 0
Self funded/Unfunded
Name [1] 244006 0
Jim Bartley
Country [1] 244006 0
New Zealand
Primary sponsor type
Other
Name
Jim Bartley
Address
10 Owens Rd.,
Epsom
Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 251409 0
None
Name [1] 251409 0
Address [1] 251409 0
Country [1] 251409 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 244110 0
Ethics committee address [1] 244110 0
Ethics committee country [1] 244110 0
Date submitted for ethics approval [1] 244110 0
10/11/2009
Approval date [1] 244110 0
Ethics approval number [1] 244110 0
NTX/09/11/102

Summary
Brief summary
Vitamin D is able to treat viral infections. As such a high potency vitamin D cream could also be useful in the treatment of the acute viral reactivation associated with acute herpes zoster.

Inflammation of cells called glial and schwann cells which surround nerves in our nervous system are also known to have a major influence on pain. Drugs that reduce inflammation in these cells are now being trialled in a number of pain conditions. One drug/ natural supplement that offers particular promise is vitamin D. Because post herpetic neuralgia responds to a number of topical medications, vitamin D is being trialled in a topical form.

If a vitamin D cream was an effective treatment for acute post herpetic neuralgia this would be a major treatment advance as it could provide a simple cost effective treatment option with minimal side effects.
Trial website
Trial related presentations / publications
Bartley J. Post herpetic neuralgia, schwann cell activation and vitamin D. Medical Hypotheses 2009 (accepted for publication)

Bartley J. Vitamin D, innate immunity and upper respiratory tract infection. JLO 2009 (accepted for publication)
Public notes

Contacts
Principal investigator
Name 30495 0
Address 30495 0
Country 30495 0
Phone 30495 0
Fax 30495 0
Email 30495 0
Contact person for public queries
Name 13742 0
Jim Bartley
Address 13742 0
10 Owens Rd.
Epsom
Auckland, 1023
Country 13742 0
New Zealand
Phone 13742 0
6496310475
Fax 13742 0
6496310478
Email 13742 0
[email protected]
Contact person for scientific queries
Name 4670 0
Jim Bartley
Address 4670 0
10 Owens Rd.
Epsom
Auckland, 1023
Country 4670 0
New Zealand
Phone 4670 0
6496310475
Fax 4670 0
6496310478
Email 4670 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
No additional documents have been identified.