A randomized clinical trial.In the available method, 100 elderly people will be selected. Based on the criteria, the researcher will be selected by targeted sampling and will be randomly assigned to two groups A (B12) and B (control group). The randomization sequence will be hidden. There are 100 packets packed in each A and B code. After obtaining informed consent, the researcher removes the desired envelope in accordance with the order and based on the group recorded in the envelope.
Settings and conduct
This research will be conducted in the elderly's home of Rasht. Intervention of the intervention group will be carried out beyond the control and control of the control group.
Participants/Inclusion and exclusion criteria
Entry criteria:
Age over 60 years old
The desire to participate in the study
The absence of a cognitive problem examined by the MMSE and AMTS tools.
Dependence on specific alcohol or drugs
Not having kidney and liver disease
Do not use hypnotic drugs
No recent use of multivitamin or similar products
Not participating in another research project
Exit criteria:
Consume less than 70% of the pills
Unwilling to continue reading
Cure for diseases requiring special treatment
Intervention groups
Supplements is vitamin B12 sublingual tablet with a daily dose of 1000 micrograms per day is manufactured by Webber Naturals, Canada, with a shelf life of 8 weeks. A batch of vitamin B12 sublingual pills will be given daily to the intervention group and will be given to all participants to take a glass of water each time before breakfast to avoid dry mouth, then substitute the tablet for complete resolution. In the control group, routine nursing care will continue and no new intervention will be received.
Main outcome variables
After 8 weeks, the Pittsburgh sleep quality questionnaire will be completed by both groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100114003064N8
Registration date:2018-05-05, 1397/02/15
Registration timing:prospective
Last update:2018-05-05, 1397/02/15
Update count:0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
Hossein Bagheri
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
bagheri@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin B12 on sleep quality of elderly
Public title
vitamin B12 in sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 60 years old
The desire to participate in the study
The absence of a cognitive problem examined by the MMSE and AMTS tools
Dependence on specific alcohol or drugs
Not having kidney and liver disease
Do not use hypnotic drugs
No recent use of multivitamin or similar products
Not participating in another research project
Exclusion criteria:
Consumption of less than 70% of the pills
Unwillingness to continue study
Having diseases requiring special treatments
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks of Volume 4 are used to create randomized sequences because individuals gradually enter the study, and also because the number of allocators is equal to each group. Seniors are based on the criteria of the researcher and to Targeted sampling will be selected and randomly divided into two groups: A (supplement B12) and B (control group). The randomization sequence will be carried out secretly. That is, there are 100 packets packed in each code A and B. After obtaining informed consent and ascertaining that the person is participating in the study, the researcher removes the desired envelope in accordance with the order and proceeds according to the group recorded in the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Because people receive medication, it is not possible to blind people. In order to prevent data leakage, the intervention of the intervention group will be carried out beyond the control and knowledge of the control group. In the pre-intervention phase, the questionnaire will be completed by a person other than the main intervener before assigning the subjects to the study. In this study, the elderly were randomly assigned to four groups of blocks (A) and B (control). After the intervention, the questionnaire is filled in by the same person who knows the group. To blow up a methodological analyst, the group of people will also be hidden for them.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahroud University of Medical Sciences
Street address
Haft Tir Square, Shahroud University of Medical Sciences
City
shahroud
Province
Semnan
Postal code
3614773955
Approval date
2018-04-30, 1397/02/10
Ethics committee reference number
IR.SHMU.REC.1397.014
Health conditions studied
1
Description of health condition studied
sleep quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified
Primary outcomes
1
Description
Sleep Quality Based on Pittsburgh Sleep Quality Test Score
Timepoint
Before and after the intervention
Method of measurement
Pittsburgh Sleep Quality Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Supplements used in this study are vitamin B12 sublingual tablets with a daily dose of 1,000 micrograms per day manufactured by Webernear, Canada, with a duration of 8 weeks according to previous studies. A daily subcutaneous supplement of vitamin B12 to humans The intervention group will be given and will be taught to all participants to take a glass of water each time before breakfast to avoid dandruff, then substitute the tablet for complete resolution.
Category
Other
2
Description
Control group: The control group will receive routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Elderly homes in Rasht
Full name of responsible person
Hossein Bagheri
Street address
Rasht، Soleimandarab
City
Rasht
Province
Guilan
Postal code
36147753917
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad-Hassan Emamian
Street address
Haft Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
emamian@shmu.ac.ir
Web page address
http://research.shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Ph.D in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
6314773955
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein bagheri
Position
َAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
3617753917
Phone
+98 232332395054
Email
bagheri@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr. Hossein Bagheri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Province
Semnan
Postal code
36147753917
Phone
+98 23 3239 5054
Email
bagheri@shmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available