Protocol summary
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Study aim
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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
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Design
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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
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Settings and conduct
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This study will be performed in Montaserieh Hospital of Mashhad. In this study, researchers, clinical caregivers, and participants are kept blind.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Nutritional status; Sugar and lipid pattern; blood pressure; Inflammatory condition; Oxidative stress; Hematological characteristics; Infection and primary kidney function
General information
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Reason for update
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Modifying the expected start and end date of illness
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Acronym
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IRCT registration information
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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
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Registration date
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2022-06-22, 1401/04/01
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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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2022-10-22, 1401/07/30
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Expected recruitment end date
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2023-10-22, 1402/07/30
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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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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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Public title
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Evaluation of the effect of curcumin in patients after kidney transplantation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 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
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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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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2022-06-01, 1401/03/11
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Ethics committee reference number
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IR.TBZMED.REC.1401.238
Health conditions studied
1
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Description of health condition studied
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patients after kidney transplantation
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ICD-10 code
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Z94.0
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ICD-10 code description
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Kidney transplant status
Primary outcomes
1
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Description
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Blood sugar
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Timepoint
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At the beginning of the study and at the end of the study
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Method of measurement
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Biochemical testing
2
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Description
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lipid profile
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Timepoint
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At the beginning of the study and at the end of the study
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Method of measurement
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Biochemical testing
3
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Description
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blood pressure
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Timepoint
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At the beginning of the study and at the end of the study
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Method of measurement
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Biochemical testing
4
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Description
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Glomerular filtration rate
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Timepoint
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At the beginning of the study and at the end of the study
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Method of measurement
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Biochemical testing
5
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Description
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delay graft function
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Timepoint
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From the beginning of the study to the end of the first week
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Method of measurement
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Need dialysis during the first week after transplantation
6
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Description
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slow graft function
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Timepoint
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From the beginning of the study to the end of the tenth day
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Method of measurement
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Serum creatinine greater than 2.5 mg/dL on day 10 after transplantation
7
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Description
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Occurrence of acute graft rejection
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Timepoint
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From the beginning of the study to the end of the study
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Method of measurement
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Permanent return to dialysis, re-transplantation or death with an active transplant
8
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Description
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Incidence of viral infections
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Timepoint
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During the study
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Method of measurement
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Diagnosis by the treating physician
Secondary outcomes
1
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Description
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weight
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Timepoint
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Beginning and end of the study
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Method of measurement
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With minimal clothing and without shoes and using Seca scales with an accuracy of 0.1 kg
2
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Description
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height
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Timepoint
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Beginning and end of the study
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Method of measurement
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Shoeless by the meter mounted to the wall with an accuracy of 0.1 cm
3
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Description
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waist circumference
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Timepoint
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Beginning and end of the study
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Method of measurement
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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
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Description
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Length of hospital stay
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Timepoint
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during study
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Method of measurement
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Number of hospitalization days
5
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Description
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Leukopenia
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Timepoint
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Beginning and end of the study
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Method of measurement
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By counting the WBC
6
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Description
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Thrombocytopenia
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Timepoint
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Beginning and end of the study
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Method of measurement
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With platelet count less than 150,000 per microliter
7
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Description
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Neutropenia
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Timepoint
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Beginning and end of the study
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Method of measurement
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With a neutrophil count of less than 1500 per microliter
Intervention groups
1
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Description
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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
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Category
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Treatment - Other
2
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Description
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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.
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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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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available