The aim of this study was to determine the effect of biotin on the intensity and frequency of muscle cramps in hemodialysis patients in Sanandaj Tohid hospital.
Design
In this double-blind, controlled clinical trial, 22 patients with chronic renal failure under hemodialysis were randomly divided into intervention and control groups using blockade.Patients and researchers were unaware of how the patients were grouped, and one of the colleagues who was not sensitive to the study results collected and recorded all the information.
Settings and conduct
The site of the study was the hemodialysis center of Tohid Hospital in Sanandaj.
Participants/Inclusion and exclusion criteria
All patients with chronic renal failure under hemodialysis who referred to the hemodialysis center of Tohid Hospital in Sanandaj, and had muscle cramps at least once a week.
Intervention groups
In the intervention group, 1 mg of biotin was administered for 12 weeks. In the first week and 12th week, the levels of biotin were measured by ELISA method.In the control group, placebo was given.
Main outcome variables
Muscle Cramps
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012789N18
Registration date:2018-04-28, 1397/02/08
Registration timing:retrospective
Last update:2018-04-28, 1397/02/08
Update count:0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-05, 1396/10/15
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Biotin on the severity and frequency of muscle cramps in patients undergoing hemodialysis
Public title
The effect of Biotin on muscle cramps in patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic renal failure
Muscle cramps at least once a week
Exclusion criteria:
Patient unwillingness to participate in the study
Sensitivity to Biotin
Necessity of taking vitamin C, vitamin E and carnitine
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated into intervention and control groups using randomized block design
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and researchers were unaware of patients grouping and all information was gathered by a colleague who was not sensitive to the results of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Ave.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2017-12-30, 1396/10/09
Ethics committee reference number
IR. MUK. REC. 1396/283
Health conditions studied
1
Description of health condition studied
Muscle Cramps
ICD-10 code
R25.2
ICD-10 code description
Cramp and spasm
Primary outcomes
1
Description
Severity , frequency and duration of muscle cramps
Timepoint
The first week and the twelfth week
Method of measurement
The severity of muscle cramps were measured using the visual analogue scale of pain and the number and duration of contractions were measured using seconds, minutes and hours.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, 1 mg of biotin was administered for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: The control group received placebo.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tohid hospital
Full name of responsible person
Sara Mohammadzadeh
Street address
Basij Sq., Geryashan St.,
City
Sanandaj
Province
Kurdistan
Postal code
66168-12131
Phone
+98 87 3328 6112
Email
sara66_med@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rasool Nasiri Kalmarzi
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
rasool_nsr@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?