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Primary outcomes
#1
empty
Total antioxidant capacity
Total antioxidant capacity
empty
ظرفیت تام آنتی اکسیدانی
ظرفیت تام آنتی اکسیدانی
empty
Before the intervention and 8 weeks after starting
Before the intervention and 8 weeks after starting
empty
قبل از مداخله و 8 هفته پس از شروع
قبل از مداخله و 8 هفته پس از شروع
empty
Spectrophotometry
Spectrophotometry
empty
اسپکتروفتومتری
اسپکتروفتومتری
#2
empty
Malondialdehyde
Malondialdehyde
empty
مالون دی آلدئید
مالون دی آلدئید
empty
Before the intervention and 8 weeks after starting
Before the intervention and 8 weeks after starting
empty
قبل از مداخله و 8 هفته پس از شروع
قبل از مداخله و 8 هفته پس از شروع
empty
Spectrophotometry
Spectrophotometry
empty
اسپکتروفتومتری
اسپکتروفتومتری
Recruitment centers
#1
Name of recruitment center - English: Rheumatology Clinic of Imam Reza Hospital in Tabriz
Name of recruitment center - Persian: کلینیک روماتولوژی بیمارستان امام رضا (ع) تبریز
Full name of responsible person - English: Fateme pourhabibi
Full name of responsible person - Persian: فاطمه پورحبیبی
Street address - English: Tabriz, Golgasht st, Imam Reza Hospital
Street address - Persian: تبریز، خیابان گلگشت، بیمارستان امام رضا(ع)
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 13 3360 5852
Fax:
Email: fatemephz1214@gmail.com
Web page address:
Name of recruitment center - English: Rheumatology Clinic of Imam Reza Hospital in Tabriz
Name of recruitment center - Persian: کلینیک روماتولوژی بیمارستان امام رضا (ع) تبریز
Full name of responsible person - English: Fateme Pourhabibi
Full name of responsible person - Persian: فاطمه پورحبیبی
Street address - English: Tabriz, Golgasht st, Imam Reza Hospital
Street address - Persian: تبریز، خیابان گلگشت، بیمارستان امام رضا(ع)
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614711
Phone: +98 13 3360 5852
Fax:
Email: Fatemephz1214@gmail.com
Web page address:
Name of recruitment center - English: Rheumatology Clinic of Imam Reza Hospital in Tabriz Name of recruitment center - Persian: کلینیک روماتولوژی بیمارستان امام رضا (ع) تبریز Full name of responsible person - English: Fateme pourhabibiPourhabibi Full name of responsible person - Persian: فاطمه پورحبیبی Street address - English: Tabriz, Golgasht st, Imam Reza Hospital Street address - Persian: تبریز، خیابان گلگشت، بیمارستان امام رضا(ع) City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614711 Phone: +98 13 3360 5852 Fax: Email: fatemephz1214Fatemephz1214@gmail.com Web page address:
Protocol summary
Study aim
Determining the effect of curcumin supplementation on some metabolic and clinical parameters in women with rheumatoid arthritis
Design
Samples were selected using available methods and randomly assigned random blocks of 8 volumes to the study groups. A random sequence is generated using the STATA14 software. During the random assignment, individuals in the groups will be classified according to menopausal status, age and BMI variables
Settings and conduct
The aim of this study is the investigate the effects of curcumin supplementation on some metabolic and clinical parameters in women with rheumatoid arthritis that referred to Rheumatology Clinic of Imam Reza Hospital in Tabriz. 24-hour dietary recall questionnaire for 3 days, anthropometric indices , IPAQ, DAS28 will be completed for each individual. At the beginning and end of the intervention, 8 ml venous blood samples will be taken and kept at -70° until testing
Participants/Inclusion and exclusion criteria
include criteria: The age range of 20-70 years in women,Diagnosis of RA according to ACR, Moderate RA (disease activity score 1.5-3.2), No infectious disease at least two weeks before study, Body mass index less than 40 kilograms per square meters, willingness to participate in the study.
exclude criteria: Pregnant or lactating women and those under hormone therapy or use of oral contraceptives, suffering from cardiovascular disease, liver and kidney failure and inflammatory disease, diabetes and hypertension, Changes in medications during the study, use of curcumin supplements and any antioxidant supplements in the last 2 months and during the study, weight loss diet, smoking.
Intervention groups
group 1 receiving curcumin (1 capsule 500 mg), group 2 placebo group (1 capsule 500 mg placebo)
Main outcome variables
serum level of lipid profile, glycemic, hs-CRP, ESR, visfatin and Disease Activity Score28 (DAS28)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100408003664N24
Registration date:2020-01-06, 1398/10/16
Registration timing:registered_while_recruiting
Last update:2021-12-23, 1400/10/02
Update count:1
Registration date
2020-01-06, 1398/10/16
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-08, 1398/09/17
Expected recruitment end date
2020-03-07, 1398/12/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of curcumin supplementation on some metabolic and clinical parameters in women with rheumatoid arthritis
Public title
The effects of curcumin supplementation in the treatment of rheumatoid arthritis disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of 20-70 years in women
Diagnosis of RA based on American College Rheumatology criteria and duration of more than one year
Moderate RA (disease activity score 1.5-3.2)
No infectious disease at least two weeks before study
Body mass index less than 40 kilograms per square meters
willingness to participate in the study.
Exclusion criteria:
Pregnant or lactating women
those under hormone therapy or use of oral contraceptives
suffering from cardiovascular disease, liver and kidney failure and inflammatory disease, diabetes and hypertension
use of lipid and glycemic lower drugs and anticoagulant drugs
Changes in medications during the study
use of curcumin supplements and any antioxidant supplements in the last 2 months and during the study
weight loss diet
smoking
Age
From 20 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected using available methods and randomly assigned random blocks of 8 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to menopausal status ,age and BMI variables.
Blinding (investigator's opinion)
Double blinded
Blinding description
The placebo and supplement will be packed in the same number in similar packages. The method of blindness will be that the supplements and placebo will be delivered to the participants by someone other than the researcher, and the researcher will remain unaware 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 Science
Street address
Tabriz University of Medical Science, Attar Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Approval date
2019-12-25, 1398/10/04
Ethics committee reference number
IR.TBZMED.REC.1398.1005
Health conditions studied
1
Description of health condition studied
rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
serum level of hs-CRP
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
ELISA
2
Description
Disease Activity Score28
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Disease Activity Score 28 Questionnaire
3
Description
serum level of visfatin
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
ELISA
4
Description
serum level of ESR
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Westergren
5
Description
Triglyceride
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Enzymatic method
6
Description
Total cholesterol
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Enzymatic method
7
Description
HDL-C
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Enzymatic method
8
Description
LDL-C
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Freidewald formula
9
Description
Fasting blood sugar
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Enzymatic method
10
Description
Insulin
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
ELISA
11
Description
Insulin resistance
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
formula
12
Description
Total antioxidant capacity
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Spectrophotometry
13
Description
Malondialdehyde
Timepoint
Before the intervention and 8 weeks after starting
Method of measurement
Spectrophotometry
Secondary outcomes
1
Description
Anthropometric measurements (BMI, WHR, WC)
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
Secca scale, non stretch meter
2
Description
Energy and nutrient intake
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
24-hour dietary recall questionnaire for 3 days (two on week days and one on a weekend or holiday)
3
Description
Physical activity
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
International Assessment of Physical Activity (IPAQ) questionnaire
Intervention groups
1
Description
Intervention group: 500 mg/day curcumin of karen company (1 capsule of 500 mg) after lunch for 2 month
Category
Treatment - Drugs
2
Description
Control group: 500 mg/day placebo(1 capsule of 500mg containing starch flour) after lunch for 2 month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic of Imam Reza Hospital in Tabriz
Full name of responsible person
Fateme Pourhabibi
Street address
Tabriz, Golgasht st, Imam Reza Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 13 3360 5852
Email
Fatemephz1214@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Alireza Ostadrahimi
Street address
Faculty of Nutrition, Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 3430
Email
nut-rc@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
Fateme Pourhabibi
Position
MSC student in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 13 3360 5852
Email
fatemephz1214@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fateme Pourhabibi
Position
MSC student in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 13 3360 5852
Email
fatemephz1214@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fateme Pourhabibi
Position
MSC student in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 13 3360 5852
Email
fatemephz1214@gmail.com
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