Aims: Fatigue is one of the most common dialysis side effects and nursing diagnoses in hemodialysis patients. It can as a Bioalarm predict cardiovascular events and mortality in hemodialysis patients. The aim of this study is evaluate the effect of vitamin C supplementation on fatigue in hemodialysis patients.
Methods: In a randomized, double-blind clinical trial, 177 patients with chronic renal failure who were referred to Baqiatallah and Chamran hospitals in Tehran, Iran were studied. They were distributed in three groups (case: one group and control: two groups). Inclusion criteria including regular hemodialysis at least 12 weeks; lack malignant and active blood disease; lack history of major surgery in the last 6 months; do not use of Carnitine; no smoking and no use of oral and injectable forms of vitamin C. Exclusion criteria including: refusal to continue the study and recent hemorrhage history and malignant disease.
In addition to demographic questionnaire, used multidimensional questionnaire (MFI), that it is determining the fatigue. Then injected Amp Vitamin C 250 mg three times weekly at the end of each dialysis session via the intravenous route, for 8 weeks in case group. In the first control group injected the same amount and at the same time of placebo and the third group received nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212212046N2
Registration date:2013-02-17, 1391/11/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-17, 1391/11/29
Registrant information
Name
Mehdi Sadeghi Shermeh
Name of organization / entity
Nursing Faculty, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 6057
Email address
m.sadeghi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Nephrology Research Center of the Baqiyatallah University of Medical SciencesNursing school of Baqiyatallah university of Medical Sciences
Expected recruitment start date
2012-08-15, 1391/05/25
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of receiving intravenous vitamin c on fatigue in patients undergoing hemodialysis in baqiatallah hospital Tehran 1391
Public title
Effect of receiving intravenous vitamin c on fatigue in patients undergoing hemodialysis in baqiatallah hospital Tehran 1391
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with continuous and regular hemodialysis with age from 18 to 80 years of hearing ability, speech, and consciousness acceptable answer to the question of taking the form of oral or intravenous vitamin c Exclusion criteria: appearance of adverse drug unwillingness to continue the study
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
190
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The study groups consisted of three treatment , placebo and control groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah university of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
Approval date
2012-04-16, 1391/01/28
Ethics committee reference number
30
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease
Primary outcomes
1
Description
Fatigue
Timepoint
Before and after intervention
Method of measurement
MFI: Standard questionnair for fatigue measurement
2
Description
Marital Satisfaction
Timepoint
Before and after intervention
Method of measurement
ENRICH Couple Scales: standard questionnaire for Marital Satisfaction measuremente
Secondary outcomes
1
Description
Hb and Hct
Timepoint
Before intervention, one month and after the end of intervention
Method of measurement
CBC labratory Test
Intervention groups
1
Description
In the Case group: Amp Vitamin C 250 mg injected three times in the everyweek at the end of each dialysis session via the intravenous route, for 8 weeks.
Category
Treatment - Drugs
2
Description
In the control group: Amp Normal salin 2.5 cc(placebo saline) injected in the everyweek at the end of each dialysis session via the intravenous route, for 8 weeks.
Category
Placebo
3
Description
In the witness group: performed no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospitals
Full name of responsible person
Mr Jalilzade- Ms Dini
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Shahid Chamran hospital
Full name of responsible person
Mr Seif
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nephrology Research Center of Baqiyatallah university of Medical Sciences
Full name of responsible person
Dr Einollahi
Street address
Tehran – Vanak Square – Mulla Sadra Street - The intersection of Sheikh Bahai - Alley martyr Nosrati
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology Research Center of Baqiyatallah university of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
School of Nursing of Baqiyatallah university of Medical Sciences
Full name of responsible person
Dr Ebadi
Street address
Tehran- Noboyad square- Araj Tee- School of Nursing of Baqiyatallah university of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Nursing of Baqiyatallah university of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing Baqiyatallah University of Medical Sciences
Full name of responsible person
Mahdi Sadeghi Shermeh
Position
Baqiyatallah university 's Faculty member
Other areas of specialty/work
Street address
Tehran – Vanak Square – Mulla Sadra Street - The intersection of Sheikh Bahai - Alley martyr Nosrati
City
Tehran
Postal code
Phone
+98 912 154 9042
Fax
Email
msshermeh@yahoo,com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing Baqiyatallah University of Medical Sciences
Full name of responsible person
Ali Tayyebi
Position
PhD student Nursing
Other areas of specialty/work
Street address
Tehran – Vanak Square – Mulla Sadra Street - The intersection of Sheikh Bahai - Alley martyr Nosrati
City
Tehran
Postal code
Phone
+98 912 105 8516
Fax
Email
tayybi ali@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
school of nursing - Baqiyatallah university of Medical Sciences. Tehran
Full name of responsible person
Vajihe Biniaz
Position
Msc student of critical care nursing
Other areas of specialty/work
Street address
tehran- Nobonyad square- Araj Tee- school of nursing - Baqiyatallah university of Medical Sciences. Tehran
City
tehran
Postal code
Phone
002177104257
Fax
Email
parvin1351@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)