Evaluation of the effect of melatonin on biomarkers of mitochondrial damage in patients with brain injury hospitalized in Alzahra hospital, Isfahan: A randomized placebo-controlled clinical trial
Setting: Intensive care units and neurology wards of Alzahra hospital affiliated to Isfahan University of Medical Sciences. Intervention: Patients with traumatic or non-traumatic brain injury will be randomized to the intervention group (will be received melatonin 20 mg per day for 5 days) or palcebo and biomarkers of mitochondrial injury will be measured before and after intervention. Patient and the researcher who measured the study outcomes will be blinded until the completion of the study and the detection of its codes.
Participants/Inclusion and exclusion criteria
Adult patients with traumatic or non-traumatic brain injury will included in the study. Patients with length of hospitalization less than 5 days and hepatic, renal or heart failure will not be included in the study.
Intervention groups
Patients in the intervention group will receive Melatonin 20 mg (four 5 mg tablets) (Razak Co., Iran) for 5 days.
Patients in the control group will receive placebo (which will produce by pharmacy faculty) with the same dose for 5 days.
Main outcome variables
The variables including S100β and MDA and CRP will be measured and compared as the main outcomes in both groups of patients at day 1 and 5 of the study. To assess neurological status of the patients, the GCS will be examined daily until the fifth day. Cognitive-Functional status using (FIM+FAM) Functional Assessment Measure will be evaluated on the first day before the intervention and three months after the intervention.The patient's mortality rate (28 days), the length of hospitalization and the number of days without ventilator (28 days) will also be assessed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081208001497N8
Registration date:2019-05-07, 1398/02/17
Registration timing:registered_while_recruiting
Last update:2019-05-07, 1398/02/17
Update count:0
Registration date
2019-05-07, 1398/02/17
Registrant information
Name
Sarah Mousavi
Name of organization / entity
Clinical Pharmacy Department, Pharmacy Faculty, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2567
Email address
smousavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of melatonin on biomarkers of mitochondrial damage in patients with brain injury hospitalized in Alzahra hospital, Isfahan: A randomized placebo-controlled clinical trial
Public title
Effect of Melatonin in brain injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients (age more than 18) who had traumatic brain injury included skull fracture, subdural hemorrhage, subarachnoid hemorrhage, brain contusion and laceration, intracerebral hemorrhage, intraventricular hemorrhage and traumatic axonal injury
Non-traumatic brain injury included strokes, infections, hypoxia and brain tumors
Admission within 72 hours after brain injury in intensive care unit or other wards such as neurology or neurosurgery
Healthy gastrointestinal tract (capable of oral ingestion or gavage of drug)
Exclusion criteria:
Length of hospitalization less than 5 days in intensive care units or other wards
Hypersensitivity to melatonin
Hepatic failure (class C according to Child-pugh)
Renal failure (need dialysis)
Severe heart failure (Class 3 and 4 according to Newyork heart association)
Sepsis within first 5 days of admission
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After the preparation of Melatonin and its placebo, each packet is assigned a code using the random number table, and the two codes are allocated to the drug and the placebo. Block randomization will performed in random blocks of four. At the end of the study, the code of each patient is decoded and the type of drug is determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient and the researcher who measuring the study outcomes are blind to the distribution of patients in the melatonin and placebo groups until the completion of the study and the detection of its codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, P.O. Box 319, Hezar-Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.032
Health conditions studied
1
Description of health condition studied
Brain injury
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
Changes in bio markers of mitochondrial injury
Timepoint
Day 1 and 5 of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Mortality rate of patients
Timepoint
28 days
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: Patients in drug group will be received Melatonin tablet (Razak Pharmaceutical company, Tehran, Iran), 20 mg daily for 5 days.
Category
Prevention
2
Description
Control group: Patients in control group will be received Melatonin tablet (Prepared in pharmacy faculty), 20 mg daily for 5
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Sarah Mousavi
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Research deputy of Isfahan University of Medical Sciences
Street address
Hezar Jerib avenue, Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Sarah Mousavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sarah Mousavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sarah Mousavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hezar Jerib avenue,Isfahan University of Medical Sciences, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746 73461
Phone
+98 31 3792 7072
Email
s.mousavi@pharm.mui.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
confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Published article
When the data will become available and for how long
One year
To whom data/document is available
All people
Under which criteria data/document could be used
No condition
From where data/document is obtainable
Scientific responded of the study
What processes are involved for a request to access data/document