Protocol summary
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Study aim
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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
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Design
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A randomized double blind placebo-controlled clinical trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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There will be two groups including curcumin and placebo that receive 500 mg curcumin or placebo daily for 7 days.
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Main outcome variables
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Inflammatory markers; oxidative stress markers; adipokines; NUTRIC score; SOFA score
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180619040151N1
Registration date:
2018-09-18, 1397/06/27
Registration timing:
prospective
Last update:
2019-10-01, 1398/07/09
Update count:
2
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Registration date
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2018-09-18, 1397/06/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-02, 1397/08/11
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Investigation of the effects of curcumin in patients hospitalized at intensive care unit
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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)
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
52
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-05, 1397/02/15
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Ethics committee reference number
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IR.TUMS.VCR.REC.1397.141
2
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Ethics committee
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Approval date
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2018-06-12, 1397/03/22
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Ethics committee reference number
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IR.SEMUMS.REC.1397.001
Health conditions studied
1
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Description of health condition studied
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Traumatic Brain Injury
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ICD-10 code
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S06.2
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ICD-10 code description
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Diffuse traumatic brain injury
Primary outcomes
1
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Description
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Serum concentration of IL-6
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By ELISA method
2
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Description
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Serum concentration of TNF-α
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By ELISA method
3
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Description
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Serum concentration of MCP-1
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By ELISA method
4
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Description
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Serum concentration of CRP
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By Immunoturbidimetry method
5
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Description
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Serum concentration of glutathione peroxidase
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By Colorimetric method
6
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Description
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Serum concentration of superoxide desmutase
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By Colorimetric method
7
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Description
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Serum concentration of leptin
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By ELISA method
8
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Description
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Serum concentration of adiponectin
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By ELISA method
9
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Description
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NUTRIC score
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By questionnaire
10
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Description
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SOFA score
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Timepoint
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The first and 8th day of the study
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Method of measurement
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By questionnaire
Intervention groups
1
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Description
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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.
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Category
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Prevention
2
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Description
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Control group: This group will receive matched placebo (lactose) added to enteral nutrition formula for 7 days.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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72
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
2
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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28
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available