The effect of curcumin supplementation on nutritional status, glucose and lipid pattern, blood pressure, inflammatory status, oxidative stress, infection, and early graft function in patients after kidney transplantation
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General information
2022-06-10, 1401/03/20
2022-10-22, 1401/07/30
2022-0610-1022 00:00:00
2022-10-22, 1401/07/30
2023-10-22, 1402/07/30
20222023-10-22 00:00:00
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Modifying the expected start and end date of illness
Modifying the expected start and end date of illness
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اصلاح تاریخ شروع و پایان بیمارگیری مورد انتظار
اصلاح تاریخ شروع و پایان بیمارگیری مورد انتظار
Recruitment centers
#1
Name of recruitment center - English: Montaserie organ transplantation hospital
Name of recruitment center - Persian: بیمارستان پیوند اعضا منتصریه
Full name of responsible person - English: Mohammad Nosrati
Full name of responsible person - Persian: محمد نصرتی
Street address - English: Khorasan Razavi, Mashhad, East door of Ferdowsi University, Public Relations Department of the University
Street address - Persian: خراسان رضوی - مشهد- خیابان امام خمینی - امام خمینی ٢۵- خیابان گلستان - مقابل سالن همایشات صدا و سیما
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177899191
Phone: +98 51 3229 1963
Fax:
Email: nosratim@tbzmed.ac.ir
Web page address:
Name of recruitment center - English: Montaserie organ transplantation hospital
Name of recruitment center - Persian: بیمارستان پیوند اعضا منتصریه
Full name of responsible person - English: Mohammad Nosrati
Full name of responsible person - Persian: محمد نصرتی
Street address - English: In front of the Radio and Television Conference Hall, Imam Khomeini Ave., Golestan Blvd., Mashhad., Khorasan Razavi
Street address - Persian: خراسان رضوی، مشهد، خیابان امام خمینی، خیابان گلستان، مقابل سالن همایشات صدا و سیما
City - English: Mashhad
City - Persian: مشهد
Province: Razavi Khorasan
Country: Iran (Islamic Republic of)
Postal code: 9177899191
Phone: +98 51 3229 1963
Fax:
Email: nosratim@tbzmed.ac.ir
Web page address:
Name of recruitment center - English: Montaserie organ transplantation hospital Name of recruitment center - Persian: بیمارستان پیوند اعضا منتصریه Full name of responsible person - English: Mohammad Nosrati Full name of responsible person - Persian: محمد نصرتی Street address - English: Khorasan Razavi, Mashhad, East door of Ferdowsi University, Public Relations DepartmentIn front of the UniversityRadio and Television Conference Hall, Imam Khomeini Ave., Golestan Blvd., Mashhad., Khorasan Razavi Street address - Persian: خراسان رضوی -، مشهد-، خیابان امام خمینی - امام خمینی ٢۵-، خیابان گلستان -، مقابل سالن همایشات صدا و سیما City - English: Mashhad City - Persian: مشهد Province: Razavi Khorasan Country: Iran (Islamic Republic of) Postal code: 9177899191 Phone: +98 51 3229 1963 Fax: Email: nosratim@tbzmed.ac.ir Web page address:
Protocol summary
Study aim
Determining the effects of curcumin supplementation on nutritional status, glucose and lipid pattern, blood pressure, inflammatory status, oxidative stress, hematological parameters, infection, and initial renal function in patients after kidney transplantation
Design
Double-blind RCT with parallel design in phase 2-3 on 40 kidney transplant recipients. The STATA software will be used for randomization using ralloc command
Settings and conduct
This study will be performed in Montaserieh Hospital of Mashhad. In this study, researchers, clinical caregivers, and participants are kept blind.
Participants/Inclusion and exclusion criteria
The age range of 18-60 years People receiving kidneys from a deceased donor Complete and informed consent to participate in the research project People who do not have other diseases that increase oxidative stress, such as IBD, liver cirrhosis, tumors, cancer People who only had a kidney transplant. Do not take curcumin, turmeric, omega-3 supplements, vitamin E, and C supplements within one month before the start of the study. Do not take antiepileptic drugs within a month before the start of the study; People with cognitive disorders such as Alzheimer's
Intervention groups
Patients in the intervention group will be given a can of curcumin capsules sufficient for 6-week. Patients received one capsule containing 500 mg of curcumin (C3 Complex, Sami Labs Ltd., Indi) and 5 mg of piperine (95% piperine, Sami Labs Ltd., Indi). Patients in the placebo group are also given a can of placebo capsules that are similar in shape and size to curcumin capsules and contain 505 mg of maltodextrin (C3 Complex, Sami Labs Ltd., Indi) for 12 weeks.
Main outcome variables
Nutritional status; Sugar and lipid pattern; blood pressure; Inflammatory condition; Oxidative stress; Hematological characteristics; Infection and primary kidney function
General information
Reason for update
Modifying the expected start and end date of illness
Acronym
IRCT registration information
IRCT registration number:IRCT20110123005670N29
Registration date:2022-06-22, 1401/04/01
Registration timing:prospective
Last update:2023-05-23, 1402/03/02
Update count:1
Registration date
2022-06-22, 1401/04/01
Registrant information
Name
Ali Tarighat-Esfanjani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 914 300 5895
Email address
tarighata@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin supplementation on nutritional status, glucose and lipid pattern, blood pressure, inflammatory status, oxidative stress, infection, and early graft function in patients after kidney transplantation
Public title
Evaluation of the effect of curcumin in patients after kidney transplantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18-60 years
People receiving kidneys from a deceased donor
Complete and informed consent to participate in the research project
People who do not have other diseases that increase oxidative stress, such as inflammatory bowel disease, liver cirrhosis, tumors and cancer
People who only had a kidney transplant
Do not take curcumin, turmeric and omega-3 supplements, vitamin E and C supplements within one month before the start of the study
Do not take antiepileptic drugs within a month before the start of the study
Exclusion criteria:
People with cognitive disorders such as Alzheimer's
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
After reaching the inclusion criteria, individuals will be randomly divided into two groups of intervention and placebo by blocking method. Blocking will be performed based on age (18-48, 60-48) and sex (male and female) and whereby the two groups will be matched in terms of age and gender. The four blocks will be created by STATA statistical software using ralloc command, which will be identified by the letters A, B, C, D. The assigned group is not known before the individual assignment.
Blinding (investigator's opinion)
Double blinded
Blinding description
All capsules (curcumin and placebo) in the same shape and color are placed and labeled in the containers by a third person, and two codes are given to individuals, and the codes will be unknown to the researcher until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
golgasht Ave., Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5155668474
Approval date
2022-06-01, 1401/03/11
Ethics committee reference number
IR.TBZMED.REC.1401.238
Health conditions studied
1
Description of health condition studied
patients after kidney transplantation
ICD-10 code
Z94.0
ICD-10 code description
Kidney transplant status
Primary outcomes
1
Description
Blood sugar
Timepoint
At the beginning of the study and at the end of the study
Method of measurement
Biochemical testing
2
Description
lipid profile
Timepoint
At the beginning of the study and at the end of the study
Method of measurement
Biochemical testing
3
Description
blood pressure
Timepoint
At the beginning of the study and at the end of the study
Method of measurement
Biochemical testing
4
Description
Glomerular filtration rate
Timepoint
At the beginning of the study and at the end of the study
Method of measurement
Biochemical testing
5
Description
delay graft function
Timepoint
From the beginning of the study to the end of the first week
Method of measurement
Need dialysis during the first week after transplantation
6
Description
slow graft function
Timepoint
From the beginning of the study to the end of the tenth day
Method of measurement
Serum creatinine greater than 2.5 mg/dL on day 10 after transplantation
7
Description
Occurrence of acute graft rejection
Timepoint
From the beginning of the study to the end of the study
Method of measurement
Permanent return to dialysis, re-transplantation or death with an active transplant
8
Description
Incidence of viral infections
Timepoint
During the study
Method of measurement
Diagnosis by the treating physician
Secondary outcomes
1
Description
weight
Timepoint
Beginning and end of the study
Method of measurement
With minimal clothing and without shoes and using Seca scales with an accuracy of 0.1 kg
2
Description
height
Timepoint
Beginning and end of the study
Method of measurement
Shoeless by the meter mounted to the wall with an accuracy of 0.1 cm
3
Description
waist circumference
Timepoint
Beginning and end of the study
Method of measurement
In the middle of the area between the lowest rib and the highest part of the pelvis at the end of natural exhalation using an inelastic tape measure without pressure on the body surface
4
Description
Length of hospital stay
Timepoint
during study
Method of measurement
Number of hospitalization days
5
Description
Leukopenia
Timepoint
Beginning and end of the study
Method of measurement
By counting the WBC
6
Description
Thrombocytopenia
Timepoint
Beginning and end of the study
Method of measurement
With platelet count less than 150,000 per microliter
7
Description
Neutropenia
Timepoint
Beginning and end of the study
Method of measurement
With a neutrophil count of less than 1500 per microliter
Intervention groups
1
Description
Intervention group: Intervention group: Curcumin capsules, one capsule containing 500 mg of curcumin (C3 complex, Sami Labs Ltd., Indi) daily with 5 mg of piperine (black pepper extract containing 95% piperine, Sami Labs Ltd., Indi) during this study. It lasts 12 weeks
Category
Treatment - Other
2
Description
Control group: Placebo capsules, which are similar in shape and size to curcumin capsules and contain 505 mg of maltodextrin (C3 complex, Sami Labs Ltd., Indi), are given daily for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaserie organ transplantation hospital
Full name of responsible person
Mohammad Nosrati
Street address
In front of the Radio and Television Conference Hall, Imam Khomeini Ave., Golestan Blvd., Mashhad., Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3229 1963
Email
nosratim@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 4280
Email
nosratim@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Tarighat Esfanjani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Sciences, Faculty of nutrition., Golgasht ave., tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7582
Email
tarighata@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Tarighat Esfanjani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of nutrition., Golgasht ave., tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7582
Email
tarighata@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Nosrati-Oskouie
Position
Ph.D candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of nutrition., Golgasht ave., tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7582
Email
nosratim@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available