Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12606000331538
Ethics application status
Approved
Date submitted
25/07/2006
Date registered
3/08/2006
Date last updated
3/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of vitamin D and calcium on bone and falls in an elderly population of Australian women selected for their history of falling
Scientific title
A randomised controlled study to evaluate the effects of vitamin D and calcium on lowering fall risk and improving bone structure in an elderly population of Australian women with low vitamin D status and a history of falling
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls and bone structure in elderly Australian women 1300 0
Condition category
Condition code
Injuries and Accidents 1391 1391 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one-year randomised double-blind clinical trial of oral supplementation of 1000 International Units of ergocalciferol per day versus placebo. All subjects received 1000 mg of calcium per day orally as calcium citrate.
Intervention code [1] 1226 0
Prevention
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 1894 0
1. Falls subjects have during the 1 year follow-up.
Timepoint [1] 1894 0
Fall data are collected every 6 weeks via telephone interview or clinic visit during the 1 year follow-up.
Primary outcome [2] 1895 0
2. Bone structure of total body, hip and forearm as measured by Dual Energy X-ray Absorptiometry and peripheral Quantitative Computed Tomography and Instant Vertebral Assessment.
Timepoint [2] 1895 0
Collected at baseline and 12 months.
Secondary outcome [1] 3349 0
1. Falls risk assessment testing using the Lord falls assessment testing approach. A test of vision (edge contrast sensitivity and visual acuity), peripheral sensation, lower limb strength, and postural sway.
Timepoint [1] 3349 0
Data are collected at baseline, 6 and 12 months.
Secondary outcome [2] 3350 0
2. Functionality using the Barthel and Timed Up and Go Test.
Timepoint [2] 3350 0
Data are collected at baseline, 6 and 12 months.
Secondary outcome [3] 3351 0
3. Biochemical markers of bone resorption and bone formation.
Timepoint [3] 3351 0
Data are collected at baseline, 6 and 12 months.
Secondary outcome [4] 3352 0
4. Calcium related biochemistry and gut calcium absorption.
Timepoint [4] 3352 0
Data are collected at baseline, 6 and 12 months.
Secondary outcome [5] 3353 0
5. Quality of life by SF-36.
Timepoint [5] 3353 0
Data are collected at baseline, 6 and 12 months.
Secondary outcome [6] 3354 0
6. Safety data including side effect data and all clinical event data.
Timepoint [6] 3354 0
Data are collected at baseline, 6 and 12 months.

Eligibility
Key inclusion criteria
A history of falling in the past 12 months; plasma 25-hydroxy vitamin D concentration less than 60 nmol/L.
Minimum age
70 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Fracture in the past 6 months; receiving bone active agents including vitamin D; a mini mental state score less than 24; bone mineral density Z score of less than -2.0; medical conditions or disorders that influence bone mineral metabolism or substantially impair balance; significant illness; laboratory evidence of renal insufficiency (creatinine more than twofold of the normal value).

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)
Subject numbers allocated by personnel having no contact with study subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated block randomisation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
294
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1524 0
Government body
Name [1] 1524 0
Australian National Health and Medical Research Council
Country [1] 1524 0
Australia
Primary sponsor type
Government body
Name
Australian National Health and Medical Research Council
Address
Country
Australia
Secondary sponsor category [1] 1339 0
University
Name [1] 1339 0
The University of Western Australia
Address [1] 1339 0
Country [1] 1339 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2947 0
Sir Charles Gairdner Hospita
Ethics committee address [1] 2947 0
Ethics committee country [1] 2947 0
Australia
Date submitted for ethics approval [1] 2947 0
Approval date [1] 2947 0
Ethics approval number [1] 2947 0
2002-041

Summary
Brief summary
This is a one-year randomised, double blind, placebo controlled study designed to evaluate the effects of ergocalciferol and calcium supplementation compared to calcium alone on fall risk and bone structure in elderly women with a plasma 25-hydroxy vitamin D level below 60 nmol/L and a history of falling in the past 12 months. Subjects were randomised by personnel having no contact with study subjects. The study subjects and the study staff remained blinded to the treatment codes during the 1 year study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36221 0
Address 36221 0
Country 36221 0
Phone 36221 0
Fax 36221 0
Email 36221 0
Contact person for public queries
Name 10415 0
Associate Professor Richard Prince
Address 10415 0
Bone and Calcium Research Group
School of Medicine and Pharmacology
University of Western Australia
Department of Endocrinology and Diabetes
1st Floor C Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 10415 0
Australia
Phone 10415 0
+61 8 93462847
Fax 10415 0
+61 8 93463221
Email 10415 0
rlprince@cyllene.uwa.edu.au
Contact person for scientific queries
Name 1343 0
Associate Professor Richard Prince
Address 1343 0
Bone and Calcium Research Group
School of Medicine and Pharmacology
University of Western Australia
Department of Endocrinology and Diabetes
1st Floor C Block
Sir Charles Gairdner Hospital
Hospital Avenue
Nedlands WA 6009
Country 1343 0
Australia
Phone 1343 0
+61 8 93462847
Fax 1343 0
+61 8 93463221
Email 1343 0
rlprince@cyllene.uwa.edu.au

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
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Documents added automatically
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