Effect of hydrolyzed collagen alone, or in combination with fish oil on wound healing, metabolic disorders and adipose derived peptides in patients with burn
Investigating the effect of hydrolyzed collagen alone or in combination with fish oil on wound healing, metabolic disorders, and adipose derived factors in patients with burns
Design
A randomized, double-blind, parallel design clinical trial, with two intervention groups (collagen alone and collagen plus fish oil) and a control group
Settings and conduct
In this clinical trial, patients with burn admitted to Motahari hospital will be included if they met the inclusion criteria. After obtaining a written consent, patients will be randomly divided to three groups to receive collagen alone (45 g daily), collagen plus fish oil (45 g daily plus 12 ml fish oil) and control (placebo with similar characteristics). In each group, 22 patients will receive the supplements for 4 weeks. The participants and main investigators will not be aware of the contents of the supplement and placebo. An individualized nutrition program will be provided for each patient. At the beginning, and at the end of weeks 2 and 4, a 10cc fasting blood sample will be taken. The levels of inflammatory and nutritional factors, anthropometric measurements, and clinical outcomes, including wound healing and hospitalization time, will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Burns of 20-45% of body surface area and degree 2 (deep) or 3, age 18-60 year, and the ability to oral intake of foods.
Non-inclusion criteria: History of any metabolic or chronic diseases, such as diabetes and organ failures, BMI<18.5 kg/m2, allergy or intolerance to protein products, pregnant women, and addicts.
Intervention groups
The protein supplement of hydrolyzed collagen will be given to patients with burn alone or with fish oil that contains essential fatty acids. The control group will receive a placebo with the same characteristics.
Main outcome variables
Pre-albumin serum levels
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20090901002394N42
Registration date:2019-03-15, 1397/12/24
Registration timing:prospective
Last update:2019-03-15, 1397/12/24
Update count:1
Registration date
2019-03-15, 1397/12/24
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hydrolyzed collagen alone, or in combination with fish oil on wound healing, metabolic disorders and adipose derived peptides in patients with burn
Public title
Effect of collagen and fish oil in burn
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 20-45% total body surface area burn
Patients with burn degree of 2 (deep) or 3
Age 18-60 years
The ability of oral intake of foods
Exclusion criteria:
History of any metabolic or chronic diseases such as diabetes, cardiovascular diseases, organ failures, and etc.
Body mass index < 18.5 kg/m2
History of allergy or intolerance to protein products
Pregnant women
Drug and alcohol addicts
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
For random allocation of individuals to the three groups, the permuted block randomization method will be applied, using a computer program, and the length of blocks will be considered randomly as 3, 6 or 9.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants in this study and the main investigator who will be involved in the conduction of the project will be blind to the content of supplement and placebo. The allocation of individuals and the provision of supplement and placebo will be carried out by a person independent of the research group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.569
Health conditions studied
1
Description of health condition studied
Burns
ICD-10 code
T21
ICD-10 code description
Burn and corrosion of trunk
2
Description of health condition studied
Burns
ICD-10 code
T22
ICD-10 code description
Burn and corrosion of shoulder and upper limb, except wrist and hand
3
Description of health condition studied
Burns
ICD-10 code
T24
ICD-10 code description
Burn and corrosion of lower limb, except ankle and foot
Primary outcomes
1
Description
Pre-albumin serum concentration
Timepoint
Baseline, end of weeks 2 and 4
Method of measurement
Biochemical assay
Secondary outcomes
1
Description
Body weight
Timepoint
Baseline, end of weeks 2 and 4
Method of measurement
Body scale
2
Description
Body mass index
Timepoint
Baseline, end of weeks 2 and 4
Method of measurement
Calculation based on the relevant formula
3
Description
Duration of hospital stay
Timepoint
Time of discharge
Method of measurement
Patient's records
4
Description
Wound healing
Timepoint
End of weeks 2 and 4
Method of measurement
Observation
5
Description
High-sensitivity C-reactive Protein serum concentration