]>
IRCT20100114003064N8 IRCT 2018-05-05 Shahroud University of Medical Sciences vitamin B12 in sleep quality The effect of vitamin B12 on sleep quality of elderly 2018-05-22 anticipated 100 Complete https://irct.ir/trial/30892 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, 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 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. 3 sleep quality. Intervention 1: 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. Intervention 2: Control group: The control group will receive routine care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Dr. Hossein Bagheri
Hafte-Tir square, Shahroud University of Medical Sciences
Shahroud Iran (Islamic Republic of) 6314773955 +98 23 3239 5054 bagheri@shmu.ac.ir Shahroud University of Medical Sciences scientific Dr. Hossein bagheri
Hafte-Tir Square, Shahroud University of Medical Sciences
Shahroud Iran (Islamic Republic of) 3617753917 +98 232332395054 bagheri@shmu.ac.ir Shahroud University of Medical Sciences Iran (Islamic Republic of) 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 60 years no limit Both Consumption of less than 70% of the pills Unwillingness to continue study Having diseases requiring special treatments G47.9 Sleep disorder, unspecified Other Other 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. Control group: The control group will receive routine care Sleep Quality Based on Pittsburgh Sleep Quality Test Score. Timepoint: Before and after the intervention. Method of measurement: Pittsburgh Sleep Quality Questionnaire. Shahroud University of Medical Sciences Approved 2018-04-30 Ethics Committee of Shahroud University of Medical Sciences Haft Tir Square, Shahroud University of Medical Sciences shahroud Semnan Iran (Islamic Republic of)