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Evaluation the effect of fish oil supplementation on glucose homeostasis and inflammatory markers in patients with mild burn

Protocol summary

Study aim
The purpose of the present study is to investigate the effect of supplementing with fish oil on glucose homeostasis, inflammation (as primary outcomes) and some secondary clinical outcomes including length of stay in ICU, length of stay in hospital, incidence of infection in adults with mild burns (<20%).
Design
A controlled, parallel-group, double-blinded, randomized clinical trial on 22 patients with mild burns. The software will be used for randomization.
Settings and conduct
Patients with mild burns who are admitted to Ayatollah Mousavi Hospital in Zanjan and need enteral nutrition, the patient and the person analyzing the outcome are not aware of the type of intervention.
Participants/Inclusion and exclusion criteria
The studied population are men and women aged 18 to 65 years, with consciousness more than 9, who have mild degree of burn, less than 20% of the body surface has been burned, and have been admitted to Ayatollah Mousavi Hospital, Zanjan, and there is no underlying diseases including thyroid, cardiovascular, cancer, diabetes, kidney and liver disorders and need nutritional support through the enteral method.
Intervention groups
fish oil (as intervention group) and corn oil (as placebo)
Main outcome variables
fasting blood glucose and insulin, ESR and CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231031059911N1
Registration date: 2023-11-29, 1402/09/08
Registration timing: prospective

Last update: 2023-11-29, 1402/09/08
Update count: 0
Registration date
2023-11-29, 1402/09/08
Registrant information
Name
Mir Ali Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3315 6300
Email address
miralimsvi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of fish oil supplementation on glucose homeostasis and inflammatory markers in patients with mild burn
Public title
omega-3 fatty acids in burn
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild burns or who with less than 20% of the body surface Patients with a level of consciousness higher than 9
Exclusion criteria:
Age less than 18 and more than 65 years Moderate to severe burns or involvement of less than 20% of the body surface Patients who need parenteral nutrition other diseases such as thyroid, cardiovascular, cancer, diabetes, kidney and liver disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization will be used as two groups with 5-number blocks including 2 participant in each group and the last block one patient. randomization unit is person and we will use random allocation software for this purpose. random coded boxes will be used for concealment. At this method, cans with similar weight, shape and color which are numbered according to the random sequence will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participating patients are aware of the general plan, but will be placed in one of the two intervention or placebo groups using the code. The outcome analyzer who will analyze the laboratory results is also not aware of the grouping and will provide the results to the researcher using the code.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Zanjan University of Medical Sciences
Street address
Azadi Blv, Deputy of Research and Thechnology, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-10-18, 1402/07/26
Ethics committee reference number
IR.ZUMS.REC.1402.163

Health conditions studied

1

Description of health condition studied
mild burn
ICD-10 code
T20-T32
ICD-10 code description
T20-T32

Primary outcomes

1

Description
fasting blood glucose
Timepoint
At the The beginning of the study (before the start of the intervention) and 21 days after the start of consumption
Method of measurement
Laboratory

2

Description
fasting insulin
Timepoint
At the The beginning of the study (before the start of the intervention) and 21 days after the start of consumption
Method of measurement
ELISA kit

3

Description
C-reactive protein
Timepoint
At the The beginning of the study (before the start of the intervention) and 21 days after the start of consumption
Method of measurement
ELISA kit

4

Description
Erythrocyte sedimentation rate
Timepoint
At the The beginning of the study (before the start of the intervention) and 21 days after the start of consumption
Method of measurement
Laboratory

Secondary outcomes

1

Description
length of hospital stay
Timepoint
from hospital admission to discarge
Method of measurement
counting the days

2

Description
length of intensive care unit stay
Timepoint
From the beginning of hospitalization to discharge from the intensive care unit
Method of measurement
counting the days

Intervention groups

1

Description
Intervention group: Fish oil (Karen Company, Iran) at a dose of 3 gram per day through gavage for 3 weeks
Category
Prevention

2

Description
Control group: Corn oil at a dose of 3 gram per day through gavage for 3 weeks
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Mir Ali Mousavi
Street address
بلوار دکتر یوسف ثبوتی
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3315 6000
Email
miralimsvi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nadri
Street address
Azadi Blv
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3342 0460
Email
Research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Seyedeh Neda Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Honarestan St., Janbazan St., Shahide avval Ave
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3370 2020
Email
neda.mousavi@zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
ِDr. Seyedeh Neda Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Honarestan St., Janbazan St., Shahide avval Ave
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3370 2020
Email
neda.mousavi@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
ِDr. Seyedeh Neda Mousavi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Honarestan St., Janbazan St., Shahide avval Ave
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3370 2020
Email
neda.mousavi@zums.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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be provided anonymously and upon request by the corresponding author of the article.
When the data will become available and for how long
after paper publication
To whom data/document is available
Vice Chancellor of University Research and Technology
Under which criteria data/document could be used
Vice Chancellor of University Research and Technology
From where data/document is obtainable
Vice Chancellor of University Research and Technology
What processes are involved for a request to access data/document
sending request to the Vice Chancellor of University Research and Technology
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