Evaluation of melatonin effects on depression and cognition function in hemodialysed patients
Design
Clinical trial with community-based and pragmatic control group, with parallel, double-blind, randomized.
Settings and conduct
Participants undergoing dialysis in Taleghani Hospital of Urmia will be will be considered eligible for enrollment if they fulfill all the inclusion criteria and none of the exclusion criteria. After describing the details of the study, patients are required to sign the consent form. The relevant questions were asked before taking the medication. Anyone not involved in the intervention will randomize between the two groups of intervention and control It blocks by age and gender by computer, then assigns participants to the groups by code generated by the computer. They also package the medicine and placebo on the basis of the code. Another random sample It is unaware of the fact that it is not involved in the intervention, according to the code on the package, the medication is given to B. Marans are delivered
Participants/Inclusion and exclusion criteria
Including criteria:
- Should be hemodialized for at least 3 months and 3 times per week and 4 hours per visit.
- Should be fluent in Farsi.
- They have visual and auditory health to complete the questionnaire.
Excluding criteria:
- Have diabetes type 1 or 2.
- Psychotic diseases.
-Take antidepressant medications
Take anti-anxiety/sedative medications.
Intervention groups
Patients in the intervention group will receive 3mg melatonin daily for two months. In the control group, placebo will be administered with no markings, with color, shape, packaging, size, odor, and taste similar to the melatonin for the same duration
Main outcome variables
Prevention and treatment of depression and cognitive impairment in patients undergoing dialysis.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110226005914N3
Registration date:2019-02-19, 1397/11/30
Registration timing:registered_while_recruiting
Last update:2019-02-19, 1397/11/30
Update count:0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Shima Hatamkhnai
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2208 5548
Email address
hatamkhani@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of melatonin on depression and cognition function in hemodialyzed patients, A randomized, double-blind, controlled trial
Public title
Effects of melatonin on depression and cognition function in hemodialyzed patients, A randomized, double-blind, controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They should be hemodialized for at least 3 months and 3 times per week and 4 hours per visit.
They should be fluent in Farsi language .
They should have visual and auditory health to complete the questionnaire.
Exclusion criteria:
Have diabetes type 1 or 2.
Have psychotic disease
Take antidepressant medicationss.
Take anti-anxiety/sedative medications.
Age
From 14 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization will be performed using a random number table generated by a computer software program and participants will be allocated to intervention or placebo group randomly. Also, the medicine and the placebo Packages are based on code. Another person who is unaware of the randomization and is not involved in the intervention, according to the code on the package, delivers the drugs to the patients.This randomization and assignment remain hidden from researchers and participants until the completion of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blocked randomization will be performed using a random number table generated by a computer software program and participants will be allocated to intervention or placebo group randomly. Also, the medicine and the placebo Packages are based on code. Another person who is unaware of the randomization and is not involved in the intervention, according to the code on the package, delivers the drugs to the patients.This randomization and assignment remain hidden from researchers and participants until the completion 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 Urmia University of Medical Sciences
Street address
Emergency Alley, Resalat street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2017-12-11, 1396/09/20
Ethics committee reference number
IR.UMSU.REC.1396.247
Health conditions studied
1
Description of health condition studied
Chronic kidney disease, Hemodialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Depression Score in the Beck Questionnaire.Cognitive impairment Score in the MMSE Questionnaire.
Timepoint
Before starting the medication and two months after taking Melatonin tablets.
Method of measurement
Beck Depression questionnare and MMSE Cognitive Impairment questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group receive melatonin at a dose of 3 mg per day for two months.
Category
Treatment - Drugs
2
Description
Control group:In the control group, patients are given a placebo with no markings, with the same color, shape, packaging, size, odor, and taste, are given at the same dose as melatonin for the same duration
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital of urmia
Full name of responsible person
Sepideh Roshan
Street address
Emergency Alley, Resalat street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hatamkhani@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebi
Street address
Emergency Ave, Resalat Blvd, urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hatamkhani@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Shima Hatamkhani
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Emergency Alley, Resalat street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hatamkhani@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shima Hatamkhani
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Emergency Ave, Resalat Blvd, urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hatamkhani@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Shima Hatamkhani
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Clinical Pharmacy
Street address
Emergency Alley, Resalat street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
hatamkhani@razi.tums.ac.ir
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
Not familiar with the procedure
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the data related to the principal outcome
When the data will become available and for how long
following publishing the article
To whom data/document is available
all the data will be available via publishing the article
Under which criteria data/document could be used
Depends on the case
From where data/document is obtainable
Emailing to the corresponder
What processes are involved for a request to access data/document