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Trial registered on ANZCTR
Registration number
ACTRN12617000223336
Ethics application status
Approved
Date submitted
7/02/2017
Date registered
10/02/2017
Date last updated
29/06/2021
Date data sharing statement initially provided
29/06/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
A community based cross-sectional study on the association between Vitamin B12 status and sleep quality
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Scientific title
A community based cross-sectional study on the association between Vitamin B12 status and sleep quality on healthy people age between 18-65 years.
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Secondary ID [1]
291107
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nutrition
301933
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Sleep
301934
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Depression
301935
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Condition category
Condition code
Diet and Nutrition
301586
301586
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0
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Other diet and nutrition disorders
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Mental Health
301618
301618
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0
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Depression
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This study aims at investigating the association between Vitamin B12 status and sleep quality in healthy people aged between 18-65 years in a community based seting in Melbourne. With the aid of activity monitor and food diary, a one week sleep and food consumption data will be collected. Moreover, blood samples will be collected to measure plasma B12 levels. Participants are required to make 2 visits at Latrobe Bundoora campus. First visit takes about 30 minutes and second take about 10 minutes. Besides, participants will be asked to wear activity monitor on their wrist for 7 days. Additionally, a 7 days food and sleep diaries as well as sleep quality and depression questionnaires will be completed in one week trial period. At the first visit, blood samples, anthropometric measurements and whole body composition (DEXA scan) data will be collected.
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Intervention code [1]
297097
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Associations between vitamin B12 and Sleep Quality parameters will be drawn. Plasma B12 markers will be measured using LCMS methods and sleep quality data will be collected using ActiGraph activity monitors.
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Assessment method [1]
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Timepoint [1]
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Blood samples for vitamin B12 assessment will be collected at first visit only.
ActiGraphs should be worn continuously for 7 days from first visit.
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Secondary outcome [1]
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Determining the links between sleep quality and depression based on objective (activity monitor) and subjective (sleep diary, depression screening questionnaire) data collected from participants.
CESD- R, a revised depression screening questionnaire developed by the Center for Epidemiologic Studies. It measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition.
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Assessment method [1]
331346
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Timepoint [1]
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Food and sleep diaries are recorded for 7 days starting from first visit similar to activity monitor.
Depression and sleep quality questionnaires can be completed any time with in the 7 days period..
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Eligibility
Key inclusion criteria
Healthy people aged between 18-65.
Willing to wear wrist activity monitor for 7 days.
Willing to record food and sleep diaries for 7 days.
Willing to give blood samples.
Willing to make 2 visits to La Trobe University, Bundoora campus.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Pregnant women.
Those who are highly dependent on medical care,
People with a cognitive impairment, intellectual disability or mental illness.
Non-English speaking.
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
Samples size calculation for this study has been made by La Trobe University statistician based on previous studies and using G power. Number of participants has been determined to be 111 to provide 95% power. This allows 10% dropout of participants to see possible correlations.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
7/06/2016
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Date of last participant enrolment
Anticipated
21/11/2017
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Actual
7/07/2017
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Date of last data collection
Anticipated
29/12/2017
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Actual
23/07/2017
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Sample size
Target
111
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Accrual to date
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Final
83
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment postcode(s) [1]
15255
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3083 - Bundoora
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Funding & Sponsors
Funding source category [1]
295549
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University
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Name [1]
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La Trobe University
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Address [1]
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School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora - 3083 Victoria.
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Country [1]
295549
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora - 3083 Victoria.
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Country
Australia
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Secondary sponsor category [1]
294371
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None
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Name [1]
294371
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Address [1]
294371
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Country [1]
294371
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296868
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La Trobe University Human Ethics Committee
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Ethics committee address [1]
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La Trobe University Human Ethics Committee, Kingsbury drive, Bundoora - 3083 Victoria.
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Ethics committee country [1]
296868
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Australia
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Date submitted for ethics approval [1]
296868
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24/03/2016
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Approval date [1]
296868
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11/05/2016
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Ethics approval number [1]
296868
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HEC 16-022
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Summary
Brief summary
We aimed at examining the association between vitamin B12 status and sleep quality of healthy people in Melbourne between age of 18-65 years with diverse dietary plans and life style at a community-based setting. Based on the known roles of B12 on proper neuronal functions and the fact that one of the symptoms of its deficiency is tiredness, we hypothesis that B12 plays crucial role in maintaining good sleep quality in humans.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
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/AnzctrAttachments/372306-Appendix 1-Participant Information Statement.pdf
(Participant information/consent)
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Attachments [2]
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/AnzctrAttachments/372306-Appendix 2-Consent Form.pdf
(Participant information/consent)
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Attachments [3]
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/AnzctrAttachments/372306-A community based cross-sectional study on the association between Vitamin B12 status and sleep quality (final-approved-pdf).pdf
(Ethics approval)
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Contacts
Principal investigator
Name
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Dr Markandeya Jois
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Address
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School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora, 3083, Victoria.
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Country
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Australia
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Phone
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+61394792172
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Fax
72282
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Email
72282
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[email protected]
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Contact person for public queries
Name
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Surafel Tegegne
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Address
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School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora, 3083, Victoria.
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Country
72283
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Australia
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Phone
72283
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+61394796039
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Fax
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Email
72283
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[email protected]
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Contact person for scientific queries
Name
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Surafel Tegegne
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Address
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School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora, 3083, Victoria.
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Country
72284
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Australia
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Phone
72284
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+61394796039
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Fax
72284
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Email
72284
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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.
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