Comparing the serum levels of copper elements in patients hospitalized in ICU in two groups of patients fed with enteral and intrameal formulas and determining the importance of paying attention to their serum levels in these patients
Design
Clinical trial with control group, with parallel groups, phase 3 on 100 patients who are divided into two groups without randomization.
Settings and conduct
This study will be conducted on 100 patients in the ICU department of Imam Khomeini Hospital in Ilam province. In this way, two groups of 50 people will be selected from among all the trauma patients hospitalized in ICU of Imam Khomeini Hospital after getting permission to remove the patient from NPO status and start enteral feeding in the form of nasogastric tube or percutaneous endoscopic gastrotomy. The first group entered the study with the enteral feeding method of hospital enteral formulas and the second group entered the study with entrameal powders, and during hospitalization, they were fed with the same method determined by their group. Due to the fact that people are selected, blinding is not done.
Participants/Inclusion and exclusion criteria
All trauma patients hospitalized in the ICU department of Imam Khomeini Hospital in Ilam province, which are divided into two groups; One group under hospital nutrition, hospital nutrition with EntraMeal powders, and the other group under nutrition with hospital enteral formulas. The inclusion criteria for the study include: 1- Complete satisfaction of the patient and the patient's family and 2- Patients in the age group of 18-75 years. Exclusion criteria include: 1- The patient's dissatisfaction with the continuation of his feeding method 2- A history or suffering from liver disease, heart disease, and kidney failure.
Intervention groups
entrameal powders
Main outcome variables
Cu and Zn serum levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240729062575N1
Registration date:2024-08-08, 1403/05/18
Registration timing:registered_while_recruiting
Last update:2024-08-08, 1403/05/18
Update count:0
Registration date
2024-08-08, 1403/05/18
Registrant information
Name
Mahsa Majidi Ghatar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3338 0526
Email address
mahsamajidii99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the level of serum Cu and Zn between patients with receiving handmade formula or entrameal hospitalized patients in the ICU setting
Public title
Determining serum levels of copper and zinc in two groups of patients receiving handmade formula or entrameal
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Complete satisfaction of the patient and the patient's family
Age group 18-75
Exclusion criteria:
Dissatisfaction of the patient from continuing his feeding method
A history or suffering from liver disease
A history or suffering from heart disease, especially heart failure
History or suffering from kidney failure
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ilam University of Medical Sciences
Street address
Banganjab- Campus of Ilam University of Medical Sciences
City
Ilam
Province
Ilam
Postal code
693917714
Approval date
2024-01-30, 1402/11/10
Ethics committee reference number
IR.MEDILAM.REC.14020234
Health conditions studied
1
Description of health condition studied
Fracture due to Trauma
ICD-10 code
M84.3
ICD-10 code description
Stress fracture
Primary outcomes
1
Description
Serum Cu and Zn level
Timepoint
24 hours after the intervention
Method of measurement
Biochemistry test of blood
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention group: In the first intervention group, patients are gavage with intramil powders that contain industrial formulas for nutrition. The amount of nutrition depends on the doctor's order and the patient's tolerance, which usually has a certain and the same amount for the patients. The second intervention group: patients are gavage with homemade soup. This soup consists of 80 grams of rice, 250 grams of boneless chicken, 300 grams of probiotic yogurt, 60 grams of liquid oil, 300 grams of probiotic yogurt, 130 grams of chopped vegetables, 240 cc of natural apple juice and 75 grams of carbohydrate powder. This soup is prepared for the patient for 24 hours, which is given to the patient in the amount of 250 cc every 3 hours.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital in Ilam
Full name of responsible person
Soheila Najafi
Street address
Banganjab , Ilam University of Medical Sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
najafi-s@medilam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Abas Maleki
Street address
Banganjab, Ilam University of Medical Sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
abbasmaleki_ilam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Soheila Najafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Banganjab, Ilam University of Medical Sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
najafi-s@medilam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Soheila Najafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Banganjab, University of Medical Sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
najafi-s@medilam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Soheila Najafi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Banganjab, University of Medical Sciences
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
najafi-s@medilam.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available