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
ACTRN12609000203257
Ethics application status
Approved
Date submitted
18/02/2009
Date registered
22/04/2009
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dose-Finding Study of the Relationship between Oral Vitamin D3 and Serum 25-Hydroxy Vitamin D3 Concentration. Protocol: ODS25
Scientific title
Dose-Finding Study of the Relationship between Oral Vitamin D3 and Serum 25-Hydroxy (OH) Vitamin D3 Concentration to achieve a target serum 25-OH vitamin D3 concentration in patients attending rheumatology outpatient clinics. Protocol: ODS25
Secondary ID [1] 296577 0
The trial is no longer active
Universal Trial Number (UTN)
Trial acronym
ODS25
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nil 4353 0
Condition category
Condition code
Musculoskeletal 4941 4941 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral vitamin D3 at starting dose of 20,000U per week followed by dose adjustment 6-weekly to achieve a target serum 25-OH vitamin D3 concentration of 140-180 nmol/L. Each participant will be on trial for 12 months, regardless of whether or not they have achieved the target serum 25-OH vitamin D3 levels.
Intervention code [1] 4400 0
Treatment: Other
Comparator / control treatment
Nil-open label single arm dose finding study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5473 0
The primary outcome is descriptive. It will document the range of oral vit D3 dose(s) required to achieve a serum concentration of 140-180 nmol/L 25-OH vitamin D3 at two successive 6-weekly measures. The serum 25-OH vitamin D3 will be determined by radioimmunoassay.
Timepoint [1] 5473 0
The achievement of target concentrations of serum 25-OH vitamin D3 at two successive 6-weekly measures is expected to occur at different times in different participants. However, all participants will continue on-study for 12 months after the initial oral vitamin D3 administration.
Secondary outcome [1] 9215 0
Nil
Timepoint [1] 9215 0
N/A

Eligibility
Key inclusion criteria
Patients attending rheumatology outpatient clinics, serum 25-hydroxy vitamin D3 < 100 nmol/L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy and lactation, women of childbearing age not using contraception, history of hypercalcemia or parathyroid disease, chronic renal failure with evidence of renal stones (calculated creatinine clearance must be > 50 ml/min by the Cockcroft-Gault equation), sarcoidosis with hypercalcemia, unsuppressed Pagets disease, metastatic bone disease, calcium pyrophosphate deposition disease (pseudogout), heterogenous calcification

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
30/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 4814 0
Self funded/Unfunded
Name [1] 4814 0
Nil
Country [1] 4814 0
Funding source category [2] 301156 0
Self funded/Unfunded
Name [2] 301156 0
Country [2] 301156 0
Australia
Primary sponsor type
Individual
Name
Michael James
Address
Rheumatology Unit
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 4092 0
None
Name [1] 4092 0
Address [1] 4092 0
Country [1] 4092 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6862 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 6862 0
Royal Adelaide Hospital,
North Terrace,
Adelaide
SA 5000
Ethics committee country [1] 6862 0
Australia
Date submitted for ethics approval [1] 6862 0
Approval date [1] 6862 0
25/02/2009
Ethics approval number [1] 6862 0
090211

Summary
Brief summary
The study will determine the range of oral doses of vitamin D that are necessary to raise blood levels of vitamin D to an extent that may have positive effects in patients with rheumatoid arthritis. This study will not examine rheumatoid arthritis outcomes, but the results will be used to plan a later study with rheumatoid patients to examine the effects of vitamin D.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29305 0
Prof Les Cleland
Address 29305 0
Rheumatology Unit
Royal Adelaide Hospital
North Tce
Adelaide
SA 5000
Australia
Country 29305 0
Australia
Phone 29305 0
+61-8-8222 5190
Fax 29305 0
Email 29305 0
[email protected]
Contact person for public queries
Name 12552 0
Prof Prof Les Cleland
Address 12552 0
Rheumatology Unit
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 12552 0
Australia
Phone 12552 0
+61-8-82225190
Fax 12552 0
Email 12552 0
[email protected]
Contact person for scientific queries
Name 3480 0
Prof Prof Les Cleland
Address 3480 0
Rheumatology Unit
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Country 3480 0
Australia
Phone 3480 0
+61-8-82225190
Fax 3480 0
Email 3480 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.