Protocol summary

Summary
This is a randomized double blind placebo-controlled clinical trial to evaluate the effect of l-carnitine on sleep quality of 56 hemodialysis patients in Emam Khomeini hospital of Shirvan. Inclusion criteria: Signing informed consent, Being on hemodialysis three times a week for at least 6 months prior to the study, age over 18. Exclusion criteria: Refusal at any time to continue the study, History of l-carnitine , vit c and vit E consumption, History of transquilizers, hypnotics or sedatives consumption, History of severe neuropsychology, cardiac, respiratory, liver disease, History of renal transplantation. After approving of the study by sciences vice chancellor of Sabzevar University of Medical Sciences and completing of written consent form by all participants in the study, Patients will be divided randomly into two equal groups. Intervention group will receive 500mg l-carnitine orally twice a day for 12 weeks and control group will receive placebo for 12 weeks. Also, the patients is asked during the study period, not to have any changes in medications, diet and exercise. At the beginning and end of the study, the Pittsburgh sleep quality index (PSQI) questionnaire will be completed by the patients to measure quality and sleep patterns.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014030516848N1
Registration date: 2014-05-03, 1393/02/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-03, 1393/02/13
Registrant information
Name
Maryam Hatami
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
hattamim@gmail.com
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2014-03-22, 1393/01/02
Expected recruitment end date
2014-06-22, 1393/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of l-carnitine supplement and placebo on sleep quality in hemodialysis patients.
Public title
Effect of l-carnitine on sleep quality in hemodialysis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Signing informed consent, Being on hemodialysis three times a week for at least 6 months prior to the study, age over 18. Exclusion criteria: Refusal at any time to continue the study, History of l-carnitine , vit c and vit E consumption, History of transquilizers, hypnotics or sedatives consumption, History of severe neuropsychology, cardiac, respiratory, liver disease, History of renal transplantation.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sabzevar University of Medical Scinces
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Approval date
2014-01-27, 1392/11/07
Ethics committee reference number
92.24.medsab.Rec

Health conditions studied

1

Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis

Primary outcomes

1

Description
sleep quality
Timepoint
before intervention and three months later
Method of measurement
PSQI=Pittsburgh sleep quality index

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will receive 500mg l-carnitine orally twice a day for 12 weeks.
Category
Treatment - Drugs

2

Description
The control group will receive tablet similar to l-carnitine as placebo orally twice a day for 12 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Foziyeh
Street address
City
Shirvan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
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
Sabzevar University of Medical Science
Full name of responsible person
Maryam Hatami
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
hattamim@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Scinces
Full name of responsible person
Zahra Estagi
Position
MSc./Member of Faculty
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
z.estagi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Scinces
Full name of responsible person
Maryam Hatami
Position
Student of MSc Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery; next to the police station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 57 1444 6070
Fax
Email
hattamim@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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