Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000364471
Ethics application status
Approved
Date submitted
5/07/2007
Date registered
9/07/2007
Date last updated
22/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Studies of Vitamin D supplements on Calcium Metabolism in Sarcoidosis
Scientific title
A one year randomised, double-blind placebo-controlled trial to evaluate the effects of vitamin D supplementation on serum calcium, urine calcium, bone turnover and bone density in subjects with sarcoidosis and vitamin D insufficiency.
Secondary ID [1] 280084 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sarcoidosis 1942 0
Condition category
Condition code
Inflammatory and Immune System 2039 2039 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weekly oral calciferol 50,000 International Units (IU) for four weeks, then monthly oral calciferol 50,000 International Units (IU) for 11 months.
Intervention code [1] 1876 0
Treatment: Drugs
Comparator / control treatment
Weekly oral placebo for four weeks, then monthly oral placebo for 11 months.
Control group
Placebo

Outcomes
Primary outcome [1] 2864 0
The difference in the change in serum calcium over 12 months between the two treatment groups.
Timepoint [1] 2864 0
Serum calcium will be measured at baseline, at weeks 2, 4, 6, 8, 12 and 16, and at months 6, 9, and 12.
Secondary outcome [1] 4827 0
The difference between changes in urine calcium at the spine, proximal femur, and total body over 12 months between the two groups.
Timepoint [1] 4827 0
Measured at baseline, at weeks 4 and 16, and at 12 months
Secondary outcome [2] 4828 0
The difference between changes in bone turnover markers at the spine, proximal femur, and total body over 12 months between the two groups.
Timepoint [2] 4828 0
Measured at baseline, at weeks 4 and 16, and at 12 months
Secondary outcome [3] 4829 0
The difference between changes in bone density at the spine, proximal femur, and total body over 12 months between the two groups.
Timepoint [3] 4829 0
Measured at baseline and at months 6 and 12.

Eligibility
Key inclusion criteria
Diagnosis of sarcoidosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Serum creatinine >0.15 mmol/L, nephrocalcinosis, hypercalcaemia (adjusted serum calcium >2.55 mmol/L), concurrent major systemic illness (except for sarcoidosis) including malignancy, established osteoporosis (Bone mineral density T score < -2.5 and a fragility fracture)

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)
Subject numbers allocated by personnel based in a different building and having no contact with study subjects
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random numbers in variable blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The people receiving the treatment (subjects), the people administering the treatment, and the people assessing the outcomes (assessors) will be blinded
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2007
Actual
4/10/2007
Date of last participant enrolment
Anticipated
Actual
22/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 524 0
New Zealand
State/province [1] 524 0

Funding & Sponsors
Funding source category [1] 2180 0
Government body
Name [1] 2180 0
Health Research Council of New Zealand
Country [1] 2180 0
New Zealand
Funding source category [2] 2181 0
Charities/Societies/Foundations
Name [2] 2181 0
Greenlane Research and Educational Fund
Country [2] 2181 0
New Zealand
Primary sponsor type
Individual
Name
Dr Mark Bolland
Address
Bone and Joint Research Group,
Department of Medicine,
University of Auckland,
85 Park Road, Grafton
Private Bag 92019,
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 1968 0
University
Name [1] 1968 0
University of Auckland Bone Research Group
Address [1] 1968 0
Bone and Joint Research Group,
Department of Medicine,
University of Auckland,
85 Park Road, Grafton
Private Bag 92019,
Auckland, 1142
Country [1] 1968 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3977 0
University of Auckland
Ethics committee address [1] 3977 0
Ethics committee country [1] 3977 0
Date submitted for ethics approval [1] 3977 0
Approval date [1] 3977 0
17/05/2007
Ethics approval number [1] 3977 0
NTX/07/03/023

Summary
Brief summary
This is a one year study designed to test whether vitamin D supplementation is safe and efficacious for patients with sarcoidosis and low vitamin D levels
Trial website
Trial related presentations / publications
Bolland MJ, Wilsher ML, Grey A, Horne AM, Fenwick S, Gamble GD, Reid IR. Randomised controlled trial of vitamin D supplementation in sarcoidosis. BMJ Open. 2013; 3:e003562.
Public notes

Contacts
Principal investigator
Name 27690 0
A/Prof Mark Bolland
Address 27690 0
Bone Research Group Department of Medicine Auckland University 85 Park Rd Grafton Private Bag 92 019 Auckland 1020
Country 27690 0
New Zealand
Phone 27690 0
6493737599
Fax 27690 0
Email 27690 0
[email protected]
Contact person for public queries
Name 11065 0
Mrs Diana Wattie
Address 11065 0
Bone Research Group
Department of Medicine
Auckland University
85 Park Rd
Grafton
Private Bag 92 019
Auckland 1020
Country 11065 0
New Zealand
Phone 11065 0
+64 9 3078970
Fax 11065 0
+64 9 3737677
Email 11065 0
[email protected]
Contact person for scientific queries
Name 1993 0
A/Prof Mark Bolland
Address 1993 0
Bone Research Group
Department of Medicine
Auckland University
85 Park Rd
Grafton
Private Bag 92 019
Auckland 1020
Country 1993 0
New Zealand
Phone 1993 0
+64 9 3737599
Fax 1993 0
+64 9 3737677
Email 1993 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
SourceTitleYear of PublicationDOI
EmbaseBone density is normal and does not change over 2 years in sarcoidosis.2014https://dx.doi.org/10.1007/s00198-014-2870-7
N.B. These documents automatically identified may not have been verified by the study sponsor.