Investigation of the effects of curcumin supplementation on inflammatory, oxidative stress and adipokine markers and nutritional and clinical status in traumatic brain injury patients receiving enteral nutrition at intensive care unit
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General information
2018-08-06, 1397/05/15
2018-11-02, 1397/08/11
2018-0811-0602 00:00:00
2019-08-06, 1398/05/15
2019-09-23, 1398/07/01
2019-0809-0623 00:00:00
Recruitment centers
#1
Name of recruitment center - English: Sina hospital
Name of recruitment center - Persian: بیمارستان سینا
Full name of responsible person - English: Hoda Sadat Zahedi
Full name of responsible person - Persian: هدی سادات زاهدی
Street address - English: Imam khomeini st., before Hasan abad Sq.,
Street address - Persian: خیابان امام خمینی، نرسیده به میدان حسن آباد، بیمارستان سینا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ١١٣٦٧٤٦٩١١
Phone: +98 21 6634 8500
Fax:
Email: hosp_sina@sina.tums.ac.ir
Web page address: http://sinahospital.tums.ac.ir/
Name of recruitment center - English: Sina hospital
Name of recruitment center - Persian: بیمارستان سینا
Full name of responsible person - English: Hoda Sadat Zahedi
Full name of responsible person - Persian: هدی سادات زاهدی
Street address - English: Before Hasan abad Square, Imam khomeini street
Street address - Persian: خیابان امام خمینی، نرسیده به میدان حسن آباد، بیمارستان سینا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ١١٣٦٧٤٦٩١١
Phone: +98 21 6634 8500
Fax:
Email: hosp_sina@sina.tums.ac.ir
Web page address: http://sinahospital.tums.ac.ir/
Name of recruitment center - English: Sina hospital Name of recruitment center - Persian: بیمارستان سینا Full name of responsible person - English: Hoda Sadat Zahedi Full name of responsible person - Persian: هدی سادات زاهدی Street address - English: Imam khomeini st., beforeBefore Hasan abad Sq.Square, Imam khomeini street Street address - Persian: خیابان امام خمینی، نرسیده به میدان حسن آباد، بیمارستان سینا City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ١١٣٦٧٤٦٩١١ Phone: +98 21 6634 8500 Fax: Email: hosp_sina@sina.tums.ac.ir Web page address: http://sinahospital.tums.ac.ir/
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice-Chancellor in Research Affairs_ Semnan University of Medical Sciences
Full name of responsible person - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تهران
Street address - English: Basij Blcd, Semnan
Street address - Persian: سمنان - بلوار بسیج - ستاد دانشگاه علوم پزشکی و خدمات بهداشتی درمانی استان سمنان
City - English: Semnan
City - Persian: ُسمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 35198 - 99951
Phone: +98 23 3344 1022
Fax:
Email: rds@semums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice-Chancellor in Research Affairs_ Semnan University of Medical Sciences
Full name of responsible person - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تهران
Street address - English: Semnan University of Medical Sciences, Basij Blvd, Semnan
Street address - Persian: سمنان - بلوار بسیج - ستاد دانشگاه علوم پزشکی و خدمات بهداشتی درمانی استان سمنان
City - English: Semnan
City - Persian: سمنان
Province: Semnan
Country: Iran (Islamic Republic of)
Postal code: 35198 - 99951
Phone: +98 23 3344 1022
Fax:
Email: rds@semums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Vice-Chancellor in Research Affairs_ Semnan University of Medical Sciences Full name of responsible person - Persian: معاونت تحقیقات و فناوری دانشگاه علوم پزشکی تهران Street address - English: Semnan University of Medical Sciences, Basij BlcdBlvd, Semnan Street address - Persian: سمنان - بلوار بسیج - ستاد دانشگاه علوم پزشکی و خدمات بهداشتی درمانی استان سمنان City - English: Semnan City - Persian: ُسمنان Province: Semnan Country: Iran (Islamic Republic of) Postal code: 35198 - 99951 Phone: +98 23 3344 1022 Fax: Email: rds@semums.ac.ir Web page address:
Protocol summary
Study aim
Determining the effects of curcumin supplementation on inflammatory, oxidative stress and adipokines and nutritional and clinical status among traumatic brain injury patients receiving enteral nutrition hospitalized at the intensive care unit
Design
A randomized double blind placebo-controlled clinical trial
Settings and conduct
This study will be performed at ICU of Sina and Shohada hospital. The researchers and patients and their first degree relatives will be blinded about the kind of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients aged 18-65 years old with Glasgow Coma Score (GCS) equal to 7 or more who are admitted ICU due to Traumatic Brain Injury (TBI) and the consent form has been signed by themselves or their first degree relatives will be considered for the study.
ٍٍExclusion criteria:
Pregnancy and lactation;
Septic patients who are hemodynamically and metabolically unstable;
Patients who are not allowed to receive nutritional support in the first 24-48 hours;
History of any kind of autoimmune disorders.
Intervention groups
There will be two groups including curcumin and placebo that receive 500 mg curcumin or placebo daily for 7 days.
Investigation of the effects of curcumin supplementation on inflammatory, oxidative stress and adipokine markers and nutritional and clinical status in traumatic brain injury patients receiving enteral nutrition at intensive care unit
Public title
Investigation of the effects of curcumin in patients hospitalized at intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 18-65 years old
Admission to ICU due to head trauma
Signing consent form by patient or first degree relatives
Glascow coma score equal to 7 or more
Exclusion criteria:
Pregnancy and lactation
Septic patients who are hemodynamically and metabolically unstable
Patients who are not allowed to receive nutritional support in the first 24-48 hours
History of any kind of autoimmune disorders
History of cancer
Chemotherapy and radiotherapy within previous month
Receiving positive inotropic agents including dopamine, dobutamine and epinephrine
History of any kind of liver failures
Severe and active hemorrhage
History of AIDS
History of known food allergy
Morbid obesity (BMI>40)
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, stratified randomization will be used. First, the participants will be stratified based on age (18-40 or 40-65 years old) ,sex (male or female) and APACHEII score (0-35 or 35-71) and then they will be allocated to intervention or placebo group based on the blocks of size 4. Blocks of size 4 have 6 modes (AABB، ABAB، ABBA، BBAA، BAAB، BABA). These modes will be available to the relevant nurse and based on these blocks, the patients will be placed in the intervention or placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The supplements (curcumin or placebo) used in this study are exactly similar in appearance. Moreover, neither researcher nor patients or their first degree relatives will not know the kind of supplements and supplements will be administered by the relevant nurse.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central Office of Tehran University of Medical Sciences, corner of Qods street, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-05-05, 1397/02/15
Ethics committee reference number
IR.TUMS.VCR.REC.1397.141
2
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Basij Blvd, Central Office of Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
99951- 35198
Approval date
2018-06-12, 1397/03/22
Ethics committee reference number
IR.SEMUMS.REC.1397.001
Health conditions studied
1
Description of health condition studied
Traumatic Brain Injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Serum concentration of IL-6
Timepoint
The first and 8th day of the study
Method of measurement
By ELISA method
2
Description
Serum concentration of TNF-α
Timepoint
The first and 8th day of the study
Method of measurement
By ELISA method
3
Description
Serum concentration of MCP-1
Timepoint
The first and 8th day of the study
Method of measurement
By ELISA method
4
Description
Serum concentration of CRP
Timepoint
The first and 8th day of the study
Method of measurement
By ELISA method
5
Description
Serum concentration of glutathione peroxidase
Timepoint
The first and 8th day of the study
Method of measurement
By ELISA method
6
Description
Serum concentration of superoxide desmutase
Timepoint
The first and 8th day of the study
Method of measurement
By ELISA method
7
Description
Serum concentration of leptin
Timepoint
The first and 8th day of the study
Method of measurement
By ELISA method
8
Description
Serum concentration of adiponectin
Timepoint
The first and 8th day of the study
Method of measurement
By ELISA method
9
Description
NUTRIC score
Timepoint
The first and 8th day of the study
Method of measurement
By questionnaire
10
Description
SOFA score
Timepoint
The first and 8th day of the study
Method of measurement
By questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will receive 500 mg curcuminoids in combination with 5 mg piperine (produced by Sabinsa company) added to enteral nutrition formula for 7 days. Because of low bio availability of curcuminoids, piperine will be added to increase it.
Category
Prevention
2
Description
Control group: This group will receive 5 mg piperine (produced by Sabinsa company) added to enteral nutrition formula for 7 days.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Hoda Sadat Zahedi
Street address
Before Hasan abad Square, Imam khomeini street
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Web page address
http://sinahospital.tums.ac.ir/
2
Recruitment center
Name of recruitment center
Shoda Tajrish hospital
Full name of responsible person
Hoda Sadat Zahedi
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Web page address
http://shmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Chancellor in Research Affairs_ Tehran University of Medical Sciences
Street address
6th floor, Central buliding of Tehran University of Medical Sciences, Corner of Qods st, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
72
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
2
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Vice-Chancellor in Research Affairs_ Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
35198 - 99951
Phone
+98 23 3344 1022
Email
rds@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?