Effect of hydrolyzed collagen alone, or in combination with fish oil on wound healing, metabolic disorders and adipose derived peptides in patients with burn
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Protocol summary
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.
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 (40 g daily), collagen plus fish oil (40 g daily plus 10 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 3, 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.
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 (4540 g daily), collagen plus fish oil (4540 g daily plus 1210 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 43, 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.
در این کارآزمایی بالینی، بیماران دچار سوختگی پذیرش شده در بیمارستان مطهری دارای معیارهای ورود و پس از اخذ رضایت نامه کتبی به طور تصادفی به سه گروه دریافت کننده کلاژن به تنهایی (45 گرم روزانه)، کلاژن به همراه روغن ماهی (45 گرم روزانه به همراه 12 میلی لیتر روغن ماهی) و کنترل (دارونما دارای ویژگی های مشابه) تقسیم خواهند شد. در هر گروه ۲۲ بیمار برای 4 هفته این درمان مکمل تغذیه ای را دریافت خواهند کرد. افراد شرکت کننده و محقق اصلی از محتوی مکمل و دارونما اطلاعی نخواهند داشت. برنامه تغذیه ای اختصاصی برای هر فرد تنظیم می شود. در ابتدای مطالعه، پایان هفته 2 و 4، 10cc نمونه خون ناشتا از بیماران گرفته می شود و سطح فاکتورهای خونی مانند عوامل التهابی و تغذیه ای، به همراه اندازه گیری های تن سنجی، و نتایج بالینی از جمله بهبود زخم و زمان بستری مورد بررسی قرار می گیرد.
در این کارآزمایی بالینی، بیماران دچار سوختگی پذیرش شده در بیمارستان مطهری دارای معیارهای ورود و پس از اخذ رضایت نامه کتبی به طور تصادفی به سه گروه دریافت کننده کلاژن به تنهایی (40 گرم روزانه)، کلاژن به همراه روغن ماهی (40 گرم روزانه به همراه 10 میلی لیتر روغن ماهی) و کنترل (دارونما دارای ویژگی های مشابه) تقسیم خواهند شد. در هر گروه ۲۲ بیمار برای 4 هفته این درمان مکمل تغذیه ای را دریافت خواهند کرد. افراد شرکت کننده و محقق اصلی از محتوی مکمل و دارونما اطلاعی نخواهند داشت. برنامه تغذیه ای اختصاصی برای هر فرد تنظیم می شود. در ابتدای مطالعه، پایان هفته 2 و 3، 10cc نمونه خون ناشتا از بیماران گرفته می شود و سطح فاکتورهای خونی مانند عوامل التهابی و تغذیه ای، به همراه اندازه گیری های تن سنجی، و نتایج بالینی از جمله بهبود زخم و زمان بستری مورد بررسی قرار می گیرد.
در این کارآزمایی بالینی، بیماران دچار سوختگی پذیرش شده در بیمارستان مطهری دارای معیارهای ورود و پس از اخذ رضایت نامه کتبی به طور تصادفی به سه گروه دریافت کننده کلاژن به تنهایی (4540 گرم روزانه)، کلاژن به همراه روغن ماهی (4540 گرم روزانه به همراه 1210 میلی لیتر روغن ماهی) و کنترل (دارونما دارای ویژگی های مشابه) تقسیم خواهند شد. در هر گروه ۲۲ بیمار برای 4 هفته این درمان مکمل تغذیه ای را دریافت خواهند کرد. افراد شرکت کننده و محقق اصلی از محتوی مکمل و دارونما اطلاعی نخواهند داشت. برنامه تغذیه ای اختصاصی برای هر فرد تنظیم می شود. در ابتدای مطالعه، پایان هفته 2 و 43، 10cc نمونه خون ناشتا از بیماران گرفته می شود و سطح فاکتورهای خونی مانند عوامل التهابی و تغذیه ای، به همراه اندازه گیری های تن سنجی، و نتایج بالینی از جمله بهبود زخم و زمان بستری مورد بررسی قرار می گیرد.
General information
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Change in the timing of the measurement of blood parameters is due to limitations and difficulties of visiting patients due to the prevalence of Covid 19. The change in the total amount of supplements is only due to the higher purity of the components, provided for this trial, and the amount of active ingredients (hydrolyzed collagen and omega-3 fatty acids) has not been changed. Adding new secondary outcomes (FGF21, NRG4, and VSS) is thanks to receiving more funding.
Change in the timing of the measurement of blood parameters is due to limitations and difficulties of visiting patients due to the prevalence of Covid 19. The change in the total amount of supplements is only due to the higher purity of the components, provided for this trial, and the amount of active ingredients (hydrolyzed collagen and omega-3 fatty acids) has not been changed. Adding new secondary outcomes (FGF21, NRG4, and VSS) is thanks to receiving more funding.
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تغییر زمان بندی اندازه گیری فاکتورهای خونی، به علت محدودیت و مشکلات مراجعات بیماران به علت شیوع کووید ۱۹ می باشد. تغییر میزان تام مکمل ها صرفا به علت خلوص بالاتر ترکیبات مواد تهیه شده برای این کارآزمایی بوده و میزان ماده موثره مورد نظر (کلاژن هیدرولیز شده و چربی های امگا-۳) تغییری نداشته است. افزودن پیامدهای ثانویه جدید (FGF21، NRG4 و VSS) به علت دریافت منابع مالی بیشتر می باشد.
تغییر زمان بندی اندازه گیری فاکتورهای خونی، به علت محدودیت و مشکلات مراجعات بیماران به علت شیوع کووید ۱۹ می باشد. تغییر میزان تام مکمل ها صرفا به علت خلوص بالاتر ترکیبات مواد تهیه شده برای این کارآزمایی بوده و میزان ماده موثره مورد نظر (کلاژن هیدرولیز شده و چربی های امگا-۳) تغییری نداشته است. افزودن پیامدهای ثانویه جدید (FGF21، NRG4 و VSS) به علت دریافت منابع مالی بیشتر می باشد.
Primary outcomes
#1
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
Secondary outcomes
#1
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#2
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#3
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#4
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#5
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#6
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#7
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#8
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#9
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#10
Baseline, end of weeks 2 and 4
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 43
ابتدا، پایان هفته 2 و 4
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 43
#11
empty
Fibroblast growth factor 21 serum concentration
Fibroblast growth factor 21 serum concentration
empty
سطوح سرمی فاکتور رشد فیبروبلاست 21
سطوح سرمی فاکتور رشد فیبروبلاست 21
empty
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 3
empty
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 3
empty
ELISA
ELISA
empty
الایزا
الایزا
#12
empty
Neuregulin 4 serum concentration
Neuregulin 4 serum concentration
empty
سطوح سرمی نورگیولین 4
سطوح سرمی نورگیولین 4
empty
Baseline, end of weeks 2 and 3
Baseline, end of weeks 2 and 3
empty
ابتدا، پایان هفته 2 و 3
ابتدا، پایان هفته 2 و 3
empty
ELISA
ELISA
empty
الایزا
الایزا
#13
empty
Vancouver Scar Scale
Vancouver Scar Scale
empty
مقیاس اسکار ونکوور
مقیاس اسکار ونکوور
empty
End of week 4
End of week 4
empty
پایان هفته 4
پایان هفته 4
empty
Scoring based on a questionnaire
Scoring based on a questionnaire
empty
امتیازدهی بر اساس پرسشنامه
امتیازدهی بر اساس پرسشنامه
Intervention groups
#1
Intervention group 1: Daily intake of 45 gr hydrolyzed collagen for 4 weeks
Intervention group 1: Daily intake of 40 gr hydrolyzed collagen for 4 weeks
Intervention group 1: Daily intake of 4540 gr hydrolyzed collagen for 4 weeks
گروه مداخله اول: دریافت روزانه 45 گرم کلاژن هیدرولیز شده برای 4 هفته
گروه مداخله اول: دریافت روزانه 40 گرم کلاژن هیدرولیز شده برای 4 هفته
گروه مداخله اول: دریافت روزانه 4540 گرم کلاژن هیدرولیز شده برای 4 هفته
#2
Intervention group 2: Daily intake of 45 gr hydrolyzed collagen plus 12 ml fish oil for 4 weeks
Intervention group 2: Daily intake of 40 gr hydrolyzed collagen plus 10 ml fish oil for 4 weeks
Intervention group 2: Daily intake of 4540 gr hydrolyzed collagen plus 1210 ml fish oil for 4 weeks
گروه مداخله دوم: دریافت روزانه 45 گرم کلاژن هیدرولیز شده و 12 میلی لیتر روغن ماهی برای 4 هفته
گروه مداخله دوم: دریافت روزانه 40 گرم کلاژن هیدرولیز شده و 10 میلی لیتر روغن ماهی برای 4 هفته
گروه مداخله دوم: دریافت روزانه 4540 گرم کلاژن هیدرولیز شده و 1210 میلی لیتر روغن ماهی برای 4 هفته
Recruitment centers
#1
Name of recruitment center - English: Motahari hospital
Name of recruitment center - Persian: بیمارستان مطهری
Full name of responsible person - English: Mostafa Dehmardei
Full name of responsible person - Persian: مصطفی ده مرده ئی
Street address - English: Shahid Motahari hospital, Rashid Yasemi St., Vali Asr avenue, Tehran
Street address - Persian: تهران، خیابان ولیعصر، خیابان رشید یاسمی، بیمارستان شهید مطهری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 8877 0031
Fax:
Email: hospital.motahari@yahoo.com
Web page address:
Name of recruitment center - English: Motahari hospital
Name of recruitment center - Persian: بیمارستان مطهری
Full name of responsible person - English: Mostafa Dehmardei
Full name of responsible person - Persian: مصطفی ده مرده ئی
Street address - English: Shahid Motahari hospital, Rashid Yasemi St., Vali Asr avenue, Tehran
Street address - Persian: تهران، خیابان ولیعصر، خیابان رشید یاسمی، بیمارستان شهید مطهری
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8877 0031
Fax:
Email: hospital.motahari@yahoo.com
Web page address:
Name of recruitment center - English: Motahari hospital Name of recruitment center - Persian: بیمارستان مطهری Full name of responsible person - English: Mostafa Dehmardei Full name of responsible person - Persian: مصطفی ده مرده ئی Street address - English: Shahid Motahari hospital, Rashid Yasemi St., Vali Asr avenue, Tehran Street address - Persian: تهران، خیابان ولیعصر، خیابان رشید یاسمی، بیمارستان شهید مطهری City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵1449614535 Phone: +98 21 8877 0031 Fax: Email: hospital.motahari@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Seyed AliJavad Mousavi
Full name of responsible person - Persian: دکتر سید علی جواد موسوی
Street address - English: Iran university of medical sciences, next to Milad tower, Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 86701
Fax:
Email: adminsite@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Seyed AliJavad Mousavi
Full name of responsible person - Persian: دکتر سید علی جواد موسوی
Street address - English: Iran university of medical sciences, next to Milad tower, Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 86701
Fax:
Email: adminsite@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Seyed AliJavad Mousavi Full name of responsible person - Persian: دکتر سید علی جواد موسوی Street address - English: Iran university of medical sciences, next to Milad tower, Hemmat Highway, Tehran Street address - Persian: تهران، بزرگراه همت، جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵1449614535 Phone: +98 21 86701 Fax: Email: adminsite@iums.ac.ir Web page address:
Protocol summary
Study aim
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 (40 g daily), collagen plus fish oil (40 g daily plus 10 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 3, 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
Change in the timing of the measurement of blood parameters is due to limitations and difficulties of visiting patients due to the prevalence of Covid 19. The change in the total amount of supplements is only due to the higher purity of the components, provided for this trial, and the amount of active ingredients (hydrolyzed collagen and omega-3 fatty acids) has not been changed. Adding new secondary outcomes (FGF21, NRG4, and VSS) is thanks to receiving more funding.
Acronym
-
IRCT registration information
IRCT registration number:IRCT20090901002394N42
Registration date:2019-03-15, 1397/12/24
Registration timing:prospective
Last update:2021-03-06, 1399/12/16
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
1449614535
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 3
Method of measurement
Biochemical assay
Secondary outcomes
1
Description
Body weight
Timepoint
Baseline, end of weeks 2 and 3
Method of measurement
Body scale
2
Description
Body mass index
Timepoint
Baseline, end of weeks 2 and 3
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