Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000540718
Ethics application status
Approved
Date submitted
8/05/2013
Date registered
14/05/2013
Date last updated
14/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin D and Mood Study
Scientific title
Effect of vitamin D supplementation on wellbeing in young adults – a randomised controlled trial
Secondary ID [1] 282471 0
NIL
Universal Trial Number (UTN)
U1111-1142-8227
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 289090 0
emotional wellbeing 289091 0
Condition category
Condition code
Mental Health 289432 289432 0 0
Depression
Mental Health 289433 289433 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin D oral capsule in six monthly doses of 50,000 IU.
A blood sample will be taken at the beginning and end of study to confirm effectiveness of the dose in increasing serum 25(OH)D. To achieve adherence, participants take the first dose under supervision, and receive text reminders to take all other 5 doses with a request to confirm having taken the dose with a return text. At the end of the study, participants will be asked to return their supplement bottles with any remaining capsules.
Participants will complete monthly online surveys on depression, wellbeing and moods.
Intervention code [1] 287118 0
Other interventions
Comparator / control treatment
Placebo, oral capsule in six monthly doses, with the same procedure of monitoring adherence and measuring wellbeing as in the active ingredient group.
Control group
Placebo

Outcomes
Primary outcome [1] 289536 0
differences in CESD scores as a measure of depressive symptomatology
Timepoint [1] 289536 0
six months after randomisation
Primary outcome [2] 289537 0
differences in positive and negative moods based on the mood circumplex
Timepoint [2] 289537 0
six months after randomisation
Secondary outcome [1] 302699 0
differences in psychological wellbeing measured through the Flourishing Scale
Timepoint [1] 302699 0
six months after randomisation

Eligibility
Key inclusion criteria
*Females aged 18-40 years
*Cell phone/internet access
*Willingness to provide repeated blood sample
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
*Current/planned vitamin D supplementation (including as part of combined supplement)
*Chronic liver and kidney disease; arteriosclerosis or cardiac function impairment; sarcoidosis and other possible granulomatous diseases
*Medication, including anticonvulsants, glucocorticoids and barbiturates that might affect vitamin D metabolism
*Overseas travel during study period (Feb-Oct 2013)

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)
Allocation carried out by the supplement provider off-site and will only be revealed at the completion of trial. Participants receive their supplements in numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Hierarchical multilevel modelling, regression, time series analysis
The sample size was determined based on being able to detect a clinically significant difference of 5 points on the depression scale used at an alpha level of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/02/2013
Actual
13/03/2013
Date of last participant enrolment
Anticipated
28/03/2013
Actual
12/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment outside Australia
Country [1] 5071 0
New Zealand
State/province [1] 5071 0
Otago

Funding & Sponsors
Funding source category [1] 287251 0
University
Name [1] 287251 0
University of Otago Research Grant
Country [1] 287251 0
New Zealand
Primary sponsor type
Individual
Name
Dr Lisa Houghton
Address
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 286002 0
Individual
Name [1] 286002 0
Dr Tamlin Conner
Address [1] 286002 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
Country [1] 286002 0
New Zealand
Secondary sponsor category [2] 286003 0
Individual
Name [2] 286003 0
Maria Polak
Address [2] 286003 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
Country [2] 286003 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289231 0
Human Ethics Committee
Ethics committee address [1] 289231 0
University of Otago
PO Box 56
Dunedin 9054
Ethics committee country [1] 289231 0
New Zealand
Date submitted for ethics approval [1] 289231 0
21/01/2013
Approval date [1] 289231 0
27/02/2013
Ethics approval number [1] 289231 0
13/031

Summary
Brief summary
The purpose of this project is to test whether vitamin D supplementation over the winter improves mood. Epidemiological evidence has linked low vitamin D status to a range of mood disorders, including major depressive disorder, seasonal affective disorder, and premenstrual syndrome. New Zealanders are low in vitamin D during the winter season; however, studies examining whether vitamin D supplementation can improve mood-related outcomes are limited.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39894 0
Dr Lisa Houghton
Address 39894 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 39894 0
New Zealand
Phone 39894 0
+6434797294
Fax 39894 0
Email 39894 0
[email protected]
Contact person for public queries
Name 39895 0
Dr Tamlin Conner
Address 39895 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
Country 39895 0
New Zealand
Phone 39895 0
+6434797624
Fax 39895 0
Email 39895 0
[email protected]
Contact person for scientific queries
Name 39896 0
Dr Lisa Houghton
Address 39896 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
Country 39896 0
New Zealand
Phone 39896 0
+6434797294
Fax 39896 0
Email 39896 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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