The effect of Nanocurcumin on gene expression of proinflammantory factors in peripheral blood mononuclear cells and serum levels of endothelial function factors in hemodialysis patients
The aime of this study is to determine the effect of nanocurcumin on gene expression of pro-inflammantory factors in peripheral blood mononuclear cells and serum levels of endothelial function factors in hemodialysis patients.
Design
This study is a double-blind clinical trial. 54 patients with inclusion criteria will be allocated to either the curcumin group or the placebo group by blocked randomization method.
Settings and conduct
Among the patients of HD ward in Taleqani Hospital 54 patients will be selected and divided into two groups by blocked randomization method, curcumin group and placebo group. Fasting blood samples will be taken at the beginning of the study and at the end of 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: age of 18-80 years, receiving 4-hour HD treatments 2-3 times per week at least for six months,
Exclusion Criteria: Patients with infectious diseases such as hepatitis, Patients with chronic inflammatory diseases, including rheumatoid arthritis and lupus, Use of steroidal and non-steroidal anti-inflammatory drugs, Intake of omega-3 fatty acids and carnitine at least 1 month before the start of the study, Liver disease and thyroid disorders, Planning for kidney transplantation during the study.
Intervention groups
Subjects in the curcumin group received 120 mg curcumin as 3 capsules, each containing 40curcumin , daily for 12 weeks, whereas the placebo group received 3 corresponding placebo capsules.
Main outcome variables
Gene expression of pro-inflammantory factors (TNF-α و IL-6) and serum levels of endothelial function factors (ICAM-1 و VCAM-1)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180328039154N1
Registration date:2018-04-25, 1397/02/05
Registration timing:registered_while_recruiting
Last update:2018-04-25, 1397/02/05
Update count:0
Registration date
2018-04-25, 1397/02/05
Registrant information
Name
Golchin Vafadar Afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3382 0423
Email address
golchin_va@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-05-20, 1397/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Nanocurcumin on gene expression of proinflammantory factors in peripheral blood mononuclear cells and serum levels of endothelial function factors in hemodialysis patients
Public title
The effect of Curcumin hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a history of at least 6 months of dialysis
Hemodialysis 2-3 times a week for 4 hours
Exclusion criteria:
Patients with infectious diseases such as hepatitis
Patients with chronic inflammatory diseases, including rheumatoid arthritis and lupus
Use of steroidal and non-steroidal anti-inflammatory drugs
Receive omega-3 fatty acids and carnitine at least 1 month before the start of the study
Liver disease and thyroid disorders
Planning for kidney transplantation during the study
No Patient's tendency to stay in study
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done through the blocking method. Considering the sample size, each block includes 6 characters and will use AAABBB combination. In the following, all possible modes from the combination will be listed and a code will be allocated to each patient then, 9 codes will be chosen by chance and given to them.
Blinding (investigator's opinion)
Double blinded
Blinding description
A code will be allocated to each patient. Medicine and placebo will be distributed according to those codes by medical team of the dialysis department.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Science and Research Branch, Islamic Azad University
Street address
Science and Research Branch, Islamic Azad University, Shohadaye Hesarak Blvd, Daneshgah Square, Sattari Expy, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
IR.IAU.SRB.REC.1395.25
Health conditions studied
1
Description of health condition studied
Hemodialyzied kidney desease patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
TNF-α
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Real-Time PCR
2
Description
IL6
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Real-Time PCR
3
Description
ICAM-1
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Blood test
4
Description
VCAM-1
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 40 mg curcumin three times a day for 12 weeks
Category
Treatment - Other
2
Description
Control group: placebo three times a day for 12 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
گلچین وفادارافشار
Street address
دانشگاه آزاد اسلامی ارومیه
City
Urmia
Province
West Azarbaijan
Postal code
5716814934
Phone
+98 44 3382 0423
Email
Golchin_va@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Azizabadi Farahani
Street address
Science and Research Branch, Islamic Azad University, Shohadaye Hesarak Blvd, Daneshgah Square, Sattari Expy, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5154
Email
f_farahany@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Oroumia University of Medical Sciences
Full name of responsible person
Yousef Rasmi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
yrasmi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Yousef Rasmi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Orjhans Street, Resalat Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
yrasmi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Golchin Vafadar Afshar
Position
ُStudent
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
دانشگاه آزاد اسلامی
City
Urmia
Province
West Azarbaijan
Postal code
57168
Phone
+98 44 3275 9180
Email
Golchin_va@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD