Study effect of treatment with L Carnitine on severity of uremic restless legs syndrome In dialysis patients
Design
This study is a double-blinded clinical trial with a parallel design and a control group. The study population will include all dialysis patients with restless legs syndrome referred to Imam Reza Hospital of Kermanshah. 82 eligible individuals will be selected conveniently. A random table is used for randomization and participants are assigned to two groups of intervention and control.
Settings and conduct
This study, which will be conducted in Imam Reza Hospital of Kermanshah, is a double-blinded one. The clinical caregiver and outcome assessor will be kept blinded to which group will receive the new drugs and which groups will receive the placebos.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Dialysis patients with restless legs syndrome; Patient informed consent
Exclusion criteria: Patients diagnosed with anxiety disorders; Patients with a diagnosis of sleep disorders
Intervention groups
The intervention group will be treated daily with 500 mg L-carnitine tablets every 12 hours for three months. The control group will receive a 500 mg daily placebo (in pill form) every 12 hours for 3 months.
Main outcome variables
Severity of Restless Legs Syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N171
Registration date:2021-07-04, 1400/04/13
Registration timing:registered_while_recruiting
Last update:2021-07-04, 1400/04/13
Update count:0
Registration date
2021-07-04, 1400/04/13
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-21, 1400/02/31
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of treatment with L Carnitine on severity of uremic restless legs syndrome in dialysis patients
Public title
Effect of L Carnitine on severity of uremic restless legs syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dialysis patients with restless legs syndrome
Patient informed consent
Exclusion criteria:
Patients diagnosed with anxiety disorders
Patients with a diagnosis of sleep disorders
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method. 82 cards are selected and numbers from 1-82 are inserted on the cards. The cards are placed in an envelope. Two of the design partners take one card out of the envelope each time and announce the card number. Paired numbers are assigned to the intervention group and odd numbers to the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs can only be identified by the serial number on the container. The serials are with the main researcher and will remain confidential until the end of the study. The clinician will not be aware of assigning individuals to study groups. The person evaluating the patients will also not know about the assignment. In fact, clinicians and outcome assessors are unaware of who is receiving the new drug. Therefore, this study will be double-blinded.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2021-04-27, 1400/02/07
Ethics committee reference number
IR.KUMS.REC.1400.088
Health conditions studied
1
Description of health condition studied
Restless leg syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome
Primary outcomes
1
Description
Severity of Restless Legs Syndrome
Timepoint
Beginning of treatment, sixth week and end of treatment (three months later)
Method of measurement
Based on clinical observation, physician and patient opinion
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive 500 mg of L-carnitine tablets (Behta) daily, every 12 hours for three months.
Category
Treatment - Drugs
2
Description
The control group will receive a 500 mg daily placebo (in pill form and Amin Pharmaceutical Company) every 12 hours for 3 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital, Parastar Boulevard
Full name of responsible person
Mahnaz Khosravi
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mahnazkhosravi141167@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@mbrc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mahnaz Khosravi
Position
Resident of Neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mahnazkhosravi141167@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Hadi Ghrebaghian
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
h_azar2001@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahnaz Khosravi
Position
Resident of Neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3427 6306
Email
mahnazkhosravi141167@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD