Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000321448
Ethics application status
Approved
Date submitted
13/06/2007
Date registered
18/06/2007
Date last updated
1/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Vitamin D and Cognition Trial
Scientific title
A randomised, placebo controlled trial of Vitamin D in older adults with mild cognitive impairment and low vitamin D concentration to prevent cognitive decline and delay progression of cognitive decline.
Secondary ID [1] 372 0
National Health & Medical Research Council (NHMRC): NHMRC Application ID 458791
Universal Trial Number (UTN)
Trial acronym
VITA-D
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment and vitamin D (25-hydroxyvitamin D) blood concentration between 50 nmol/L and 12.5 nmol/L. 1867 0
Condition category
Condition code
Mental Health 1963 1963 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 1964 1964 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
18-month trial of 1000 IU Vitamin D daily by oral tablet.
Intervention code [1] 1823 0
Prevention
Comparator / control treatment
Placebo (soyabean oil tablet indistinguishable from active tablet).
Control group
Placebo

Outcomes
Primary outcome [1] 2778 0
Cognitive Decline as measured by the Cambridge Examination for mental disorders in the Elderly - Cognitive section (CAMCOG)
Timepoint [1] 2778 0
Measured at 6, 12, and 18 month follow-up.
Secondary outcome [1] 4678 0
Cognitive decline as tested by the Digit-symbol coding task, California Verbal Learning Scale-Revised, or CERAD battery
Timepoint [1] 4678 0
At 18-month follow-up.
Secondary outcome [2] 4679 0
Development of dementia
Timepoint [2] 4679 0
Any time during study (Clinical Dementia Rating)
Secondary outcome [3] 4680 0
Depression as measured by the PHQ-9 questionnaire.
Timepoint [3] 4680 0
At 6, 12 and 18-month follow-ups
Secondary outcome [4] 4681 0
Quality of Life as measured by the SF-12 questionnaire.
Timepoint [4] 4681 0
At 18-months
Secondary outcome [5] 4682 0
Walking speed as measured by the 6-meter walk and Get-up and Go task.
Timepoint [5] 4682 0
At 6 and 18-month follow-ups
Secondary outcome [6] 4683 0
Quadriceps strength as measured by the knee extension task.
Timepoint [6] 4683 0
At 6 and 18-month follow-ups
Secondary outcome [7] 4684 0
Lower limb strength as measured by the Timed Sit-to-Stand.
Timepoint [7] 4684 0
At 6 and 18-month follow-ups
Secondary outcome [8] 4685 0
Dynamic single leg balance as measured by the Step Test.
Timepoint [8] 4685 0
At 6 and 18-month follow-ups
Secondary outcome [9] 4686 0
Standing balance as measured by the Functional Reach task.
Timepoint [9] 4686 0
At 6 and 18-month follow-ups
Secondary outcome [10] 4687 0
Weight and waist girth.
Timepoint [10] 4687 0
At 6 and 18-month follow-ups
Secondary outcome [11] 4688 0
Fear of falling in activities of daily living, as measured by the Modified Falls Efficacy Scale.
Timepoint [11] 4688 0
At 6 and 18-month follow-ups
Secondary outcome [12] 4689 0
Activity level, as measured by the Human Activity Profile.
Timepoint [12] 4689 0
Measured at 6 and 18-month follow-ups

Eligibility
Key inclusion criteria
Adults with mild cognitive impairment (-1.5 standard deviations below norm on any task in the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) neuropsychological battery), over 65 years of age, Vitamin D concentration between 12.5 and 50 nmol/L at baseline.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of osteoporosis requiring treatment, no informant available, severe physical or medical illness that would preclude completion of the trial, hearing or visual impairment that would preclude assessments, already in an intervention trial, clinical history of stroke, fall in the last 3 months, heart attack in the last 3 months, fall with fracture over the age of 65, history of kidney or bladder stones, current acute depression, history of schizophrenia, current diagnosis of dementia.

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)
Concealed allocation with sequential study numbers being given to subjects found to be eligible by trial personnel, and then administration of pre-filled, numbered containers obtained from a remote site (Royal Perth Hospital Pharmacy) that holds the allocation schedule. Trial personnel (who decide who is eligible) do not have access to the allocation schedule and are not involved with the process of packing medications or numbering containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Study medication (vitamin D or placebo) will be randomised using computer generated lists, by Royal Perth Hospital pharmacy staff who have no direct contact with study participants.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects and trial personnel (those responsible for recruiting and assessing subjects) will be blinded to treatment allocation until conclusion of trial and finalisation of data
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2102 0
Government body
Name [1] 2102 0
National Health and Medical Research Council Dementia Research Grants Program
Country [1] 2102 0
Australia
Primary sponsor type
Individual
Name
Professor Nicola Lautenschlager
Address
WA Centre for Health & Ageing, University of Western Australia, M573 35 Stirling Highway Crawley WA 6009
Country
Australia
Secondary sponsor category [1] 1909 0
Individual
Name [1] 1909 0
Professor Leon Flicker
Address [1] 1909 0
WA Centre for Health & Ageing, University of Western Australia 35 Stirling Highway Crawley WA 6009
Country [1] 1909 0
Australia
Secondary sponsor category [2] 1910 0
Individual
Name [2] 1910 0
Professor Osvaldo Almeida
Address [2] 1910 0
WA Centre for Health & Ageing, University of Western Australia, M573 35 Stirling Hwy Crawley WA 6009
Country [2] 1910 0
Australia
Secondary sponsor category [3] 1911 0
Individual
Name [3] 1911 0
Dr Chris Beer
Address [3] 1911 0
WA Centre for Health & Ageing, University of Western Australia, 35 Stirling Highway Crawley WA 6009
Country [3] 1911 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3893 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 3893 0
Ethics committee country [1] 3893 0
Australia
Date submitted for ethics approval [1] 3893 0
Approval date [1] 3893 0
08/02/2007
Ethics approval number [1] 3893 0
EC 2007/079
Ethics committee name [2] 3894 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [2] 3894 0
Ethics committee country [2] 3894 0
Australia
Date submitted for ethics approval [2] 3894 0
Approval date [2] 3894 0
21/02/2007
Ethics approval number [2] 3894 0
Ethics committee name [3] 3895 0
Mercy Hospital, Mount Lawley Ethics Committee
Ethics committee address [3] 3895 0
Ethics committee country [3] 3895 0
Australia
Date submitted for ethics approval [3] 3895 0
Approval date [3] 3895 0
16/04/2007
Ethics approval number [3] 3895 0
EC 2007/079

Summary
Brief summary
The primary aim of this 18-month randomised, double-blind, placebo-controlled clinical trial is to establish whether vitamin D supplementation can delay progression of cognitive decline amongst older adults with Mild Cognitive Impairment (MCI) who have low vitamin D concentrations (between 12.5 and 50 nmol/L).
The main hypothesis of this study is that older adults with MCI randomised to a 18-month treatment with vitamin D will experience significantly less cognitive decline (as measured with the CAMCOG) at the end of the 18-months follow-up than subjects with MCI randomised to placebo. Secondary outcomes of interest for this study include quality of life, gait, balance and muscle strength.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27637 0
Address 27637 0
Country 27637 0
Phone 27637 0
Fax 27637 0
Email 27637 0
Contact person for public queries
Name 11012 0
Professor Nicola Lautenschlager
Address 11012 0
University of Western Australia WA Centre for Health & Ageing, M573, 35 Stirling Highway Crawley, 6009 WA,
Country 11012 0
Australia
Phone 11012 0
61-8-92242855
Fax 11012 0
61-8-92248009
Email 11012 0
[email protected]
Contact person for scientific queries
Name 1940 0
Professor Nicola Lautenschlager
Address 1940 0
University of Western Australia
WA Centre for Health & Ageing
M573
35 Stirling Highway Crawley
WA 6009
Country 1940 0
Australia
Phone 1940 0
61-8-92242855
Fax 1940 0
61-8-92248009
Email 1940 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
EmbasePrevention of sporadic Alzheimer's disease: Lessons learned from clinical trials and future directions.2015https://dx.doi.org/10.1016/S1474-4422%2815%2900153-2
N.B. These documents automatically identified may not have been verified by the study sponsor.