Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000631909
Ethics application status
Approved
Date submitted
14/07/2009
Date registered
21/06/2011
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin D Deficiency in Human Immunodeficiency Virus
Scientific title
The effect of Cholecalciferol and dietary advice on Vitamin D levels in participants with Human Immunodeficiency Virus Infection
Secondary ID [1] 262421 0
'Nil'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D Deficiency 237248 0
Human Immundeficiency Infection 237263 0
Condition category
Condition code
Diet and Nutrition 239565 239565 0 0
Other diet and nutrition disorders
Infection 239585 239585 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supplementation with 5000 IU Cholecalciferol orally, daily for 12 months, in addition to a single 30 minute interview with dietitian at baseline with provision of dietary advice regarding sources of vitamin D in diet plus advice regarding safe levels of sunlight exposure
Intervention code [1] 236935 0
Treatment: Drugs
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238362 0
Proportion of Human Immunodeifiency Virus (HIV) patients who achieve normal Vitamin D levels (>50 nmol/l) measured by blood analysis
Timepoint [1] 238362 0
12 months following supplementation
Secondary outcome [1] 244802 0
Effect of vitamin D supplementation on bone markers (Calcium, phosphate, Alkaline Phosphatase, Parathryroid Hormone) by blood assays
Timepoint [1] 244802 0
12 months following supplementation
Secondary outcome [2] 244827 0
Effect of vitamin D supplementation on immunological markers (CD4 lymphocyte cell counts) by blood assays
Timepoint [2] 244827 0
12 months following supplementation

Eligibility
Key inclusion criteria
Documented HIV infection
Age greater than 18 years
Vitamin D deficiency (<50 nmol/l)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
On vitamin D supplementation

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)
Once an HIV patient with vitamin D deficiency is identified, they are referred for consideration of volunteering to participate in the study. All patents will be prescribed the intervention. No concealment procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/07/2009
Actual
2/07/2009
Date of last participant enrolment
Anticipated
Actual
23/06/2010
Date of last data collection
Anticipated
Actual
18/05/2011
Sample size
Target
40
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12394 0
The Alfred - Prahran
Recruitment postcode(s) [1] 24661 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 237325 0
Hospital
Name [1] 237325 0
The Alfred Hospital Research Trust
Country [1] 237325 0
Australia
Funding source category [2] 267266 0
Commercial sector/Industry
Name [2] 267266 0
Merck, Sharp & Dohme
Country [2] 267266 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital Research Trust
Address
Commercial Rd
Melbourne
Victoria, 3004
Country
Australia
Secondary sponsor category [1] 236810 0
None
Name [1] 236810 0
Address [1] 236810 0
Country [1] 236810 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239426 0
The Alfred Hospital Research and Ethics Committee
Ethics committee address [1] 239426 0
Ethics committee country [1] 239426 0
Australia
Date submitted for ethics approval [1] 239426 0
Approval date [1] 239426 0
02/07/2009
Ethics approval number [1] 239426 0
AH 118/09

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29896 0
Ms Julia Price
Address 29896 0
Department of Nutrition, Alfred Hospital, Commercial Rd, Melbourne, Victoria 3004
Country 29896 0
Australia
Phone 29896 0
+61 3 9076 3063
Fax 29896 0
Email 29896 0
J. Price@alfred.org.au
Contact person for public queries
Name 13143 0
Miss Julia Price
Address 13143 0
Nutrition Department
Alfred Hospital
Commercial Rd
Melbourne
Victoria, 3004
Country 13143 0
Australia
Phone 13143 0
+61 3 9076 3063
Fax 13143 0
Email 13143 0
J.Price@alfred.org.au
Contact person for scientific queries
Name 4071 0
Miss Julia Price
Address 4071 0
Nutrition Department
The Alfred Hospital
Commercial Rd
Melbourne
Victoria, 3004
Country 4071 0
Australia
Phone 4071 0
+61 3 9076 3063
Fax 4071 0
Email 4071 0
J.Price@alfred.org.au

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


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.