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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000213943
Ethics application status
Approved
Date submitted
23/02/2011
Date registered
28/02/2011
Date last updated
28/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Maastricht Index(MI) between patients receiving a standard enteral feeding product or kitchen made enteral feeding in an Intensive Care Unit(ICU) of a teaching hospital
Scientific title
a double blind randomized clinical trial to evaluate Maastricht Index (MI) between patients receiving a standard enteral feeding product or kitchen made enteral feeding in an ICU of a teaching hospital in Iran
Secondary ID [1] 259666 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
enteral feeding 261236 0
Condition category
Condition code
Diet and Nutrition 259381 259381 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
fresubin (a standard enteral feeding available in Iran) 150 cc every 3 hours via enteral feeding tube for 7 days
Intervention code [1] 258095 0
Treatment: Other
Comparator / control treatment
Kitchen made product consisted of meat extract and potato extract 150 cc every 3 hours via enteral feeding tube for 7 days
Control group
Active

Outcomes
Primary outcome [1] 262202 0
assesment of maastricht index in baseline, third day and 7th day after enteral feeding
Timepoint [1] 262202 0
baseline , 3 and 7 days after starting enteral feeding
Secondary outcome [1] 273307 0
evaluation of laboratory parameters such as: hemoglobin, Albumin, blood sugar, cholosterol and Trigleceride
Timepoint [1] 273307 0
baseline , 3 and 7 days after starting enteral feeding

Eligibility
Key inclusion criteria
All inpatients of ICU of shahid rajaii hospital need enteral feeding
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
diabetic , renal failure, hepatic failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3222 0
Iran, Islamic Republic Of
State/province [1] 3222 0

Funding & Sponsors
Funding source category [1] 258555 0
University
Name [1] 258555 0
Shahid Beheshti University of Medical Sciences
Address [1] 258555 0
Department of Clinical Pharmacy, Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Country [1] 258555 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Shahid Beheshti University of Medical Sciences
Address
Department of Clinical Pharmacy, Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 257693 0
None
Name [1] 257693 0
Address [1] 257693 0
Country [1] 257693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260526 0
Shahid Beheshti university of Medical sciences ethical committee
Ethics committee address [1] 260526 0
Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Ethics committee country [1] 260526 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 260526 0
02/12/2008
Approval date [1] 260526 0
12/12/2008
Ethics approval number [1] 260526 0

Summary
Brief summary
Maastricht index is an international parameter for assessment of nutritional status in hospitalized patients. This study was designed to compare Maastricht index between patients who received a standard enteral feeding product and kitchen made nutrition in ICU of a teaching hospital.
Method: A Randomized Clinical trial was done in ICU of shahid Rajaii hospital in Tehran, Iran. 60 patients under enteral feeding enrolled the study and evaluated for 10 days. Patients were randomized to receive fresubin (a standard enteral feeding available in Iran) or kitchen made nutrition that is routine nutrition delivery in most hospitals of Iran. In both groups nasogastric tubes were used for delivery of nutrients. Assessments of patients on the basis of Maastricht index were done at baseline, third day and seventh day after beginning enteral feeding.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32261 0
Address 32261 0
Country 32261 0
Phone 32261 0
Fax 32261 0
Email 32261 0
Contact person for public queries
Name 15508 0
Mohammad Abbsinazari
Address 15508 0
Department of Clinical Pharmacy, Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Country 15508 0
Iran, Islamic Republic Of
Phone 15508 0
+982188873704
Fax 15508 0
+982188873704
Email 15508 0
farshadpharm@yahoo.com
Contact person for scientific queries
Name 6436 0
Mohammad Abbsinazari
Address 6436 0
Department of Clinical Pharmacy, Faculty of Pharmacy,Valiasr St,Nyayesh Junction, Tehran, Iran , 1991953381
Country 6436 0
Iran, Islamic Republic Of
Phone 6436 0
+982188873704
Fax 6436 0
+982188873704
Email 6436 0
farshadpharm@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary