Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000318088
Ethics application status
Approved
Date submitted
20/04/2010
Date registered
20/04/2010
Date last updated
2/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of vitamin D supplementation vs placebo on cognitive and emotional outcomes
Scientific title
A randomised controlled trial of vitamin D supplementation vs placebo on cognitive and emotional outcomes in healthy volunteers
Secondary ID [1] 251635 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive function in healthy volunteers 257220 0
Condition category
Condition code
Mental Health 257358 257358 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin D (Cholecalciferol 5000 IU) capsules, 1 capsule daily for 6 weeks
Intervention code [1] 256341 0
Treatment: Drugs
Comparator / control treatment
Identical looking placebo capsules (same size microcellulose capsule), 1 capsule daily for 6 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 258264 0
Response inhibition - stop signal task
Timepoint [1] 258264 0
Measured at baseline and 6 weeks
Primary outcome [2] 258265 0
Spatial working memory - N-back task
Timepoint [2] 258265 0
Measured at baseline and 6 weeks
Primary outcome [3] 258266 0
Cognitive flexibility - set shifting task
Timepoint [3] 258266 0
Measured at baseline and 6 weeks
Secondary outcome [1] 263924 0
Peters Delusional Inventory
Timepoint [1] 263924 0
Measured at baseline and 6 weeks
Secondary outcome [2] 263925 0
Speech perception - White noise task
Timepoint [2] 263925 0
Measured at baseline and 6 weeks
Secondary outcome [3] 263926 0
Aggression and hostility - Aggression Questionaire
Timepoint [3] 263926 0
Measured at baseline and 6 weeks
Secondary outcome [4] 263927 0
Anger - State Trait Anger Expression Inventory
Timepoint [4] 263927 0
Measured at baseline and 6 weeks
Secondary outcome [5] 263928 0
Anxiety symptoms - State Trait Anxiety Inventory
Timepoint [5] 263928 0
Measured at baseline and 6 weeks
Secondary outcome [6] 263929 0
Depressive symptoms - Beck Depression Questionnaire
Timepoint [6] 263929 0
Measured at baseline and 6 weeks
Secondary outcome [7] 263931 0
Sustained attention - Sustained Attention to Response Test
Timepoint [7] 263931 0
Measured at baseline and 6 weeks

Eligibility
Key inclusion criteria
aged 18 years or over
provision of consent to participate.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) current use of vitamin D or calcium supplements;
2) having past adverse reactions to vitamin supplements;
3) current or recent use of psychotropic medications or medications which may influence vitamin D absorption (e.g. cholestyramine, orlistat)
4) current or past diagnosis of psychotic disorders;
5) serious neurologic illnesses including stroke, brain tumours, head trauma, multiple sclerosis, epilepsy, movement disorders or migraine in treatment;
6) drug dependency on alcohol or illicit substances;
6) intellectual disability
7) pregnancy or current breast feeding, or potential to become pregnant during the trial;
8) history of severe renal impairment,
9) recent or current use of immunosuppressive therapy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256842 0
Hospital
Name [1] 256842 0
Queensland Centre for Mental Health Research
Country [1] 256842 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 256118 0
Hospital
Name [1] 256118 0
Queensland Centre for Mental Health Research
Address [1] 256118 0
Queensland Centre for Mental Health Research
Level 3 Dawson House
The Park
Wacol, QLD 4076
Country [1] 256118 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258860 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 258860 0
Ethics committee country [1] 258860 0
Australia
Date submitted for ethics approval [1] 258860 0
Approval date [1] 258860 0
Ethics approval number [1] 258860 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31076 0
Address 31076 0
Country 31076 0
Phone 31076 0
Fax 31076 0
Email 31076 0
Contact person for public queries
Name 14323 0
Angela Dean
Address 14323 0
Queensland Brain Insitute
Building 79, Upland Rd
The University of Queensland
St Lucia QLD 4072
Country 14323 0
Australia
Phone 14323 0
61 7 3346 6300
Fax 14323 0
Email 14323 0
[email protected]
Contact person for scientific queries
Name 5251 0
Angela Dean
Address 5251 0
Queensland Brain Insitute
Building 79, Upland Rd
The University of Queensland
St Lucia QLD 4072
Country 5251 0
Australia
Phone 5251 0
61 7 3346 6300
Fax 5251 0
Email 5251 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.