Trial Review

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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
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.
Secondary ID [1] 291107 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition 301933 0
Sleep 301934 0
Depression 301935 0
Condition category
Condition code
Diet and Nutrition 301586 301586 0 0
Other diet and nutrition disorders
Mental Health 301618 301618 0 0
Depression

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 297097 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300993 0
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.
Timepoint [1] 300993 0
Blood samples for vitamin B12 assessment will be collected at first visit only.
ActiGraphs should be worn continuously for 7 days from first visit.
Secondary outcome [1] 331346 0
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.
Timepoint [1] 331346 0
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..

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/06/2016
Date of last participant enrolment
Anticipated
21/11/2017
Actual
7/07/2017
Date of last data collection
Anticipated
29/12/2017
Actual
23/07/2017
Sample size
Target
111
Accrual to date
Final
83
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 15255 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 295549 0
University
Name [1] 295549 0
La Trobe University
Country [1] 295549 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora - 3083 Victoria.
Country
Australia
Secondary sponsor category [1] 294371 0
None
Name [1] 294371 0
Address [1] 294371 0
Country [1] 294371 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296868 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 296868 0
La Trobe University Human Ethics Committee, Kingsbury drive, Bundoora - 3083 Victoria.
Ethics committee country [1] 296868 0
Australia
Date submitted for ethics approval [1] 296868 0
24/03/2016
Approval date [1] 296868 0
11/05/2016
Ethics approval number [1] 296868 0
HEC 16-022

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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1443 1443 0 0
/AnzctrAttachments/372306-Appendix 1-Participant Information Statement.pdf (Participant information/consent)
Attachments [2] 1444 1444 0 0
/AnzctrAttachments/372306-Appendix 2-Consent Form.pdf (Participant information/consent)
Attachments [3] 1446 1446 0 0
/AnzctrAttachments/372306-A community based cross-sectional study on the association between Vitamin B12 status and sleep quality (final-approved-pdf).pdf (Ethics approval)

Contacts
Principal investigator
Name 72282 0
Dr Markandeya Jois
Address 72282 0
School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora, 3083, Victoria.
Country 72282 0
Australia
Phone 72282 0
+61394792172
Fax 72282 0
Email 72282 0
[email protected]
Contact person for public queries
Name 72283 0
Surafel Tegegne
Address 72283 0
School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora, 3083, Victoria.
Country 72283 0
Australia
Phone 72283 0
+61394796039
Fax 72283 0
Email 72283 0
[email protected]
Contact person for scientific queries
Name 72284 0
Surafel Tegegne
Address 72284 0
School of Life Sciences, La Trobe University, Kingsbury drive, Bundoora, 3083, Victoria.
Country 72284 0
Australia
Phone 72284 0
+61394796039
Fax 72284 0
Email 72284 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.