Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000273280
Ethics application status
Approved
Date submitted
2/03/2009
Date registered
15/05/2009
Date last updated
15/05/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Vitamin D2 and Vitamin D3 on serum 25-hydroxyvitamin D and parathyroid concentrations in healthy adult participants
Scientific title
Effect of vitamin D2 and vitamin D3 supplementation on serum 25-hydroxyvitamin D and parathyroid concentrations in healthy adult participants
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evaluating the relative potencies of equal molar doses of vitamin D2 and D3 4403 0
Condition category
Condition code
Diet and Nutrition 4656 4656 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
vitamin D2 (ergocalciferol), vitamin D3 (cholecalciferol), both provided in a daily oral dose of 1000 IU, for a period of 6 months
Intervention code [1] 4136 0
Treatment: Other
Comparator / control treatment
placebo, containing micro-crystalline cellulose, in a daily oral dose, for a period of 6 months
Control group
Placebo

Outcomes
Primary outcome [1] 5522 0
serum 25-hydroxyvitamin D, measured in blood, by liquid chromatography mass spectrometry
Timepoint [1] 5522 0
baseline, week4, week8, week12, 6 months after intervention commencement
Secondary outcome [1] 9297 0
parathyroid hormone, measured in blood by electrochemiluminescence immunoassay (ELECSYS)
Timepoint [1] 9297 0
baseline, week4, week8, week12, 6 months after intervention commencement

Eligibility
Key inclusion criteria
Healthy males and females
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Body mass index greater than 27kg/m2
Chronic liver and kidney disease
Individuals taking medication, including anticonvulsants, glucocorticoids and barbiturates that might affect vitamin D metabolism
Individuals who are currently taking a vitamin D supplement

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)
treatments will be coded by a third party (someone not involved in the study) and the code will be placed in a sealed envelope, which will not be opened until data collection, and analysis is completed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random list was generated using STATA software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 1605 0
New Zealand
State/province [1] 1605 0

Funding & Sponsors
Funding source category [1] 4584 0
Charities/Societies/Foundations
Name [1] 4584 0
The Otago Medical Research Foundation
Country [1] 4584 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Department of Human Nutrition
Address
University of Otago
PO Box 56
Dunedin
9054
Country
New Zealand
Secondary sponsor category [1] 4134 0
None
Name [1] 4134 0
Address [1] 4134 0
Country [1] 4134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6632 0
University of Otago Ethics Committee
Ethics committee address [1] 6632 0
University of Otago
PO Box 56
Dunedin
9054
Ethics committee country [1] 6632 0
New Zealand
Date submitted for ethics approval [1] 6632 0
08/12/2008
Approval date [1] 6632 0
19/12/2008
Ethics approval number [1] 6632 0
08/187

Summary
Brief summary
Vitamin D is available in two forms, vitamin D2 and vitamin D3. Vitamin D3 is synthesized in the human body, whereas vitamin D2 is commonly used in supplements. It is not clear if the two forms have equivalent effects on serum 25-hydroxyvitamin D concentrations – the best measure of vitamin D status. To date, results of studies have yielded conflicting results because of problems with study design including small number of participants, short study duration and confounding effects of seasonal changes in serum 25-hydroxyvitamin D concentrations. We propose to evaluate the effects of daily doses of both vitamin D2 and vitamin D3 on serum changes in serum 25-hydroxyvitamin D and parathyroid concentrations over a sufficient period of time (4 mo). As most clinical and public health recommendations do not distinguish between vitamin D2 and D3, the results of this study will provide a definitive answer to whether these 2 distinct forms should be regarded as equivalent and interchangeable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29337 0
Address 29337 0
Country 29337 0
Phone 29337 0
Fax 29337 0
Email 29337 0
Contact person for public queries
Name 12584 0
Lisa Houghton
Address 12584 0
PO Box 56
Dunedin
9054
Country 12584 0
New Zealand
Phone 12584 0
+64 3 479 7294
Fax 12584 0
Email 12584 0
[email protected]
Contact person for scientific queries
Name 3512 0
Lisa Houghton
Address 3512 0
PO Box 56
Dunedin
9054
Country 3512 0
New Zealand
Phone 3512 0
+64 3 479 7294
Fax 3512 0
Email 3512 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.