A clinical trial to compare the effectiveness of citrulline supplementation with placebo on tolerance and complications of nutritional in patients admitted to the intensive care unit
To compare the effectiveness of citrulline supplementation with placebo on tolerance and complications of nutritional in patients admitted to the intensive care unit.
Design
This randomized and double-blind clinical trial with parallel and control groups will be conducted on 60 patients who will be randomly selected using the random number table.
Settings and conduct
Patients admitted to the intensive care unit to Imam Reza Hospital, Mashhad, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the citrulline supplementation and control will receive placebo. The participants and person responsible for data collection are blind to group allocation and the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged between 18 and 75 years; non-participation in any other intervention research design.
Exclusion criteria: Having citrulline allergies; pregnant women; the patient dies in the first 4 days of admission; patients who require of only parenteral nutrition.
Intervention groups
The intervention group will receive 3 mg citrulline supplementation (Daghigh Tajhiz Ario, Tehran, Iran) per day for 14 days.
The control group will receive placebo (There is no citrulline in it, but it has the same color, taste, structure and shape as citrulline, produced by the research center of faculty of pharmacy, Mashhad University of Medical Sciences) per day for 14 days.
Main outcome variables
Evaluation and comparison of nutritional status, gastrointestinal bleeding, duration of hospital and intensive care unit stay, duration of mechanical ventilation and 28-day mortality rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220508054780N2
Registration date:2023-04-26, 1402/02/06
Registration timing:prospective
Last update:2023-04-26, 1402/02/06
Update count:0
Registration date
2023-04-26, 1402/02/06
Registrant information
Name
Benyamin Fazli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2711
Email address
fazlib@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of citrulline supplementation with placebo on tolerance and complications of nutritional in patients admitted to the intensive care unit
Public title
The effectiveness of citrulline supplementation on tolerance and complications of nutritional in patients admitted to the intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18 and 75 years
Non-participation in any other intervention research design
Exclusion criteria:
Having citrulline allergies
Pregnant women
The patient dies in the first 4 days of admission
Patient who require of only parenteral nutrition
Age
From 18 years old to 75 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be simple randomly assigned to two groups using a random table type and opaque envelopes will be used for concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and responsible for data collection are blind to group allocation and the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2023-01-09, 1401/10/19
Ethics committee reference number
IR.MUMS.IRH.REC.1401.054
Health conditions studied
1
Description of health condition studied
Tolerance and complications of nutritional in patients admitted to the intensive care unit
ICD-10 code
Y57.8
ICD-10 code description
Other drugs and medicaments
Primary outcomes
1
Description
Nutritional status
Timepoint
Before, 2, 7 and 14 days after intervention
Method of measurement
Using by NUTRIC score questionnaire
2
Description
Gastrointestinal bleeding
Timepoint
Before, 2, 7 and 14 days after intervention
Method of measurement
Using by the sequential organ failure assessment (SOFA) score
Secondary outcomes
1
Description
Duration of hospital and intensive care unit stay
Timepoint
From the time of admission to the end of the intervention
Method of measurement
Based on the number of days the patient was hospitalized
2
Description
Duration of mechanical ventilation
Timepoint
From the time of admission to the end of the intervention
Method of measurement
The rate of using of patient the ventilator
3
Description
28-day mortality rate
Timepoint
28 days after intervention
Method of measurement
Based on days after intervention
Intervention groups
1
Description
Intervention group: The intervention group will receive 3 mg citrulline supplementation (Daghigh Tajhiz Ario, Tehran, Iran) per day for 14 days.
Category
Treatment - Drugs
2
Description
Control group: The control group will receive placebo (There is no citrulline in it, but it has the same color, taste, structure and shape as citrulline, produced by the research center of faculty of pharmacy, Mashhad University of Medical Sciences) per day for 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Benyamin Fazli
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
fazlib@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Benyamin Fazli
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
fazlib@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Benyamin Fazli
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
fazlib@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Benyamin Fazli
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Imam Reza Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2711
Email
fazlib@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The research data obtained from the main outcomes of the study can be shared freely as 'open data'.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
Under which criteria data/document could be used
The research data is exclusively accessible to the researchers working at universities and centers for scientific research.
From where data/document is obtainable
Benyamin Fazli provides the data analysis to the applicants via email: fazlib@mums.ac.ir.
What processes are involved for a request to access data/document
Applicants can send emails to him and receive a response within a week.