The aim of this clinical trial is to evaluate the effect of melatonin administration on sleep disorders in patients undergoing hemodialysis in Arak Valiasr Hospital. At first step for all of the patients who meet the inclusion criteria (age 18-85, no disability for communication and willing to participate) PSQI sleep quality questionnaire will be completed. According to this survey patients who have scores above 5 will be assuming to have sleep disorder. After obtaining informed written consent, these patients randomly will allocate in 2 groups (case and control). Case and placebo groups are going to receive melatonin (3mg shiff manufacturer) and placebo every night for 6 weeks, respectively. A 3-day washout will precede the switch from melatonin to placebo or vice versa. The sleep quality score, lipids profile (LDL, HDL, total Cholesterol, TG), Hemoglobin and recieved erythropoietin doses will be measured at the beginning, 6w and 12w in both arms. Statistical analysis will perform using SPSS 17.0 and two-sample paired-group t test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108077253N1
Registration date:2011-10-15, 1390/07/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-10-15, 1390/07/23
Registrant information
Name
Mahnaz Edalat-nejad
Name of organization / entity
Arak university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3630
Email address
hosseintabar@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of melatonin on sleep disturbances of hemodialysis patients.
Public title
The effect of melatonin on sleep disturbances of hemodialysis patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: ESRD patients undergoing hemodialysis >3 months with PSQI score equal or >5/ age:18-85/capable of giving informed consent
exclusion: severe allergy to melatonin/unstable angina or hearth failure class 4/ pregnancy or breast feeding/ severe medical or psychological disease/history of melatonin consumption
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Alamalhoda st.
City
Arak
Postal code
Approval date
2011-06-15, 1390/03/25
Ethics committee reference number
90-109-9
Health conditions studied
1
Description of health condition studied
Chronic Renal Failure
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
2
Description of health condition studied
Sleep disturbance
ICD-10 code
F51
ICD-10 code description
Nonorganic sleep disorders
Primary outcomes
1
Description
Sleep quality
Timepoint
Before intervention and 6th and 12th week of intervention.
Method of measurement
PSQI questionnaire
Secondary outcomes
1
Description
Serum lipids
Timepoint
At study beginning, 6 and 12 weeks
Method of measurement
Valiasr lab
2
Description
Erythropoitin dosages
Timepoint
0, 6th and 12th weeks
Method of measurement
Providing from dialysis sheets review
3
Description
Serum hemoglobin levels
Timepoint
0, 6th and 12th weeks
Method of measurement
Valiasr lab
Intervention groups
1
Description
Tab melatonin 3mg/day. every night at 8 pm for 6 weeks.
Category
Treatment - Drugs
2
Description
Tab placebo(melatonin placebo). every night at 8 pm for 6 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr.Mahnaz Edalat-nejad
Street address
Valiasr hospital, Valiasre squre.
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Office of Vice Chancellor for Research of Arak Medical Science University
Full name of responsible person
Dr.Saeed Changizi Ashtiyani
Street address
Arak University of Medical Sciences, Sardasht st.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Office of Vice Chancellor for Research of Arak Medical Science University
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
Arak University of Medical Sciences
Full name of responsible person
Dr. Tahereh Hossein-tabar
Position
Internal medicine assisstant/ assisstant
Other areas of specialty/work
Street address
Internal medicine department, Valiasr hospital.
City
Arak
Postal code
Phone
+98 86 1417 3630
Fax
Email
hosseintabar@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Edalat-nejad. Mahnaz
Position
Assisstant professor in adult nephrology
Other areas of specialty/work
Street address
Internal medicine department-nephrology ward, Valiasr hospital.
City
Arak
Postal code
Phone
+98 86131220162
Fax
+98 86 1417 3630
Email
mahedalat@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.Edalat-nejad.Mahnaz
Position
Nephrologist/Assisstant professor
Other areas of specialty/work
Street address
Internal medicine department- Nephrology ward, Valiasr hospital.
City
Arak
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)