Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000642482
Ethics application status
Approved
Date submitted
13/12/2007
Date registered
17/12/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effect of vitamin D supplementation on insulin resistance and bone health in South Asian women
Scientific title
The effect of vitamin D supplementation on insulin resistance and bone markers in South Asian women with hypovitaminosis D and raised insulin resistance (HOMA-IR)
Universal Trial Number (UTN)
Trial acronym
Surya Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insulin resistance 2627 0
bone mineral density 2628 0
bone turnover 2629 0
Condition category
Condition code
Diet and Nutrition 2744 2744 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin D (25(OH)D3) supplement, 4000 international units (IU) per day in the form of an oral capsule, for 6 months. Vitamin D is synthesised in the skin in the presence of sunlight, but can also be taken as a dietary supplement.
Intervention code [1] 2366 0
Treatment: Other
Comparator / control treatment
Placebo. The placebo capsule is of identical appearance as the active, but without the vitamin D content. It is taken for the same duration i.e. daily for 6 months
Control group
Placebo

Outcomes
Primary outcome [1] 3635 0
Insulin resistance as measured by Homeostatis Model Assessment of Insulin Resistance (HOMA-IR)
Timepoint [1] 3635 0
Baseline, 3 months and 6 months
Secondary outcome [1] 6095 0
Collagen C-telopeptide (CTX)/osteocalcin ratios measured in serum from fasting blood samples
Timepoint [1] 6095 0
Baseline, 3 months and 6 months

Eligibility
Key inclusion criteria
Female, South Asian
Minimum age
20 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Vitamin D supplements >1000IU per day, medicated for diabetes, chronic kidney disease

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)
Randomisation and allocation into pairs was performed by the manufacturer using "NQuery" software. Randomisation and allocation was fully concealed from the researcher.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are paired according to (1) age and (2) BMI. A coin is then tossed to allocate either the A or B bottle of a pair of bottles to the first (alphabetical) name of the pair.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 713 0
New Zealand
State/province [1] 713 0
Auckland

Funding & Sponsors
Funding source category [1] 2883 0
Charities/Societies/Foundations
Name [1] 2883 0
New Zealand Lottery Grants Board
Country [1] 2883 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Institute of Food, Nutrition and Human Health (IFNHH)
B22 Eastbourne Road,
Massey University
Albany
Auckland
Country
New Zealand
Secondary sponsor category [1] 2606 0
None
Name [1] 2606 0
Address [1] 2606 0
Country [1] 2606 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4826 0
Massey University Human Ethics Committee - Southern A
Ethics committee address [1] 4826 0
Office of the Assistant the VC
Massey University
Turitea Campus
Private Bag 11222
Palmerston North
Ethics committee country [1] 4826 0
New Zealand
Date submitted for ethics approval [1] 4826 0
20/11/2006
Approval date [1] 4826 0
20/12/2006
Ethics approval number [1] 4826 0
06/67

Summary
Brief summary
People of South Asian origin are anecdotally thought to be deficient in vitamin D, partly due to skin colour and partly to other lifestyle/cultural reasons. They are also known to be at greater risk of developing type 2 diabetes than the general population. There is some evidence that vitamin D deficiency plays a role in the aetiology of diabetes. The aim of this trial is to test the hypotheses that insulin resistance will improve when vitamin D deficiency is addressed.
Trial website
Trial related presentations / publications
P R von Hurst, C Matthys, W Stonehouse, J Coad. Is Wasit circumference a useful indicator of markers of metabolic syndrome in South Asian women living in New Zealand? Presentation to International Diabetes Federation - West Pacific, Wellington April 2008
Public notes

Contacts
Principal investigator
Name 28240 0
Address 28240 0
Country 28240 0
Phone 28240 0
Fax 28240 0
Email 28240 0
Contact person for public queries
Name 11397 0
Pamela von Hurst
Address 11397 0
Institute of Food, Nutrition and Human Health (IFNHH)
B22 Eastbourne Road,
Massey University
Albany
Auckland
Country 11397 0
New Zealand
Phone 11397 0
09 4140800 ext 41205
Fax 11397 0
Email 11397 0
[email protected]
Contact person for scientific queries
Name 2325 0
Pamela von Hurst
Address 2325 0
Institute of Food, Nutrition and Human Health (IFNHH)
B22 Eastbourne Road,
Massey University
Albany
Auckland
Country 2325 0
New Zealand
Phone 2325 0
09 4140800 ext 41205
Fax 2325 0
Email 2325 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
Dimensions AIStudy Protocol – Metabolic syndrome, vitamin D and bone status in South Asian women living in Auckland, New Zealand: A randomised, placebo-controlled, double-blind vitamin D intervention2008https://doi.org/10.1186/1471-2458-8-267
Dimensions AIAbstracts2009https://doi.org/10.1111/j.1747-0080.2009.01351.x
N.B. These documents automatically identified may not have been verified by the study sponsor.