The aim of this study was to determine the effect of vitamin B12 supplementation on fatigue, depression, anxiety and stress in hemodialysis patients. High plasma concentrations of total homocysteine was considered as a criterion. Study was on hemodialysis patients from selected hospitals No.1 and No.2. The sample size was 86 patients involved intravenous injection of ml/mcg 100 Vitamin B12 after dialysis process, which was carried out three times a week for two months and then by the end of the intervention, to assess the durability of vitamin B12, there was no intervention for a month(washout). 21-item questionnaire measure of depression, anxiety, stress and multidimensional questionnaire measuring fatigue at the beginning and end of each month of study was completed by participants. At the beginning of Intervention, at the end of the second month of intervention and end of washout, laboratory studies were conducted.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012122611892N1
Registration date:2013-01-28, 1391/11/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-28, 1391/11/09
Registrant information
Name
Samira Savari
Name of organization / entity
Faculty of Nursing of Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7710 3725
Email address
rnehrir1739@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nephrology and Urology Research center Faculty of Nursing of Baqiyatallah University of Medical Science.
Responsible person: Dr Behzad Eynollahi
Expected recruitment start date
2011-12-21, 1390/09/30
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin B12 supplementation on levels of fatigue, depression, anxiety and stress hemodialysis patients
Public title
Effect of vitamin B12 on reducing fatigue, depression, anxiety and stress in hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria: a minimum of 18 years; a minimum literacy; a least 3 months have passed since the first dose of hemodialysis; a high concentration of plasma total homocysteine
exclusion criteria: people who did research during strenuos crisis(acute illness, hospitalization, surgery extended) or emotional (grief, divorce)they are excluded
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Molla sadra Ave,Vanak
City
Tehran
Postal code
Approval date
2011-11-29, 1390/09/08
Ethics committee reference number
28
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.0
ICD-10 code description
Preparatory care for dialysis
Primary outcomes
1
Description
Fatigue
Timepoint
Befor Intervention, one and two months after intervention, One month after the end of intervention
Method of measurement
MFI
Secondary outcomes
1
Description
Total homocysteine plasma
Timepoint
Befor intervention, two months after the intervention, one month after the end of intervention
Method of measurement
laboratory tests
Intervention groups
1
Description
Infusion intravenous vitamin B12 two months in the end of hemodialysis proccece