Protocol summary
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Study aim
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Determining the effect of curcumin supplementation on some metabolic and clinical parameters in women with rheumatoid arthritis
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Design
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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
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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group 1 receiving curcumin (1 capsule 500 mg), group 2 placebo group (1 capsule 500 mg placebo)
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Main outcome variables
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serum level of lipid profile, glycemic, hs-CRP, ESR, visfatin and Disease Activity Score28 (DAS28)
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:
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
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Registration date
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2020-01-06, 1398/10/16
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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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2019-12-08, 1398/09/17
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Expected recruitment end date
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2020-03-07, 1398/12/17
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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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Effects of curcumin supplementation on some metabolic and clinical parameters in women with rheumatoid arthritis
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Public title
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The effects of curcumin supplementation in the treatment of rheumatoid arthritis disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 70 years old
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Gender
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Female
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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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 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.
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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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2019-12-25, 1398/10/04
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Ethics committee reference number
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IR.TBZMED.REC.1398.1005
Health conditions studied
1
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Description of health condition studied
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rheumatoid arthritis
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ICD-10 code
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M05
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ICD-10 code description
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Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
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Description
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serum level of hs-CRP
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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ELISA
2
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Description
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Disease Activity Score28
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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Disease Activity Score 28 Questionnaire
3
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Description
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serum level of visfatin
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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ELISA
4
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Description
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serum level of ESR
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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Westergren
5
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Description
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Triglyceride
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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Enzymatic method
6
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Description
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Total cholesterol
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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Enzymatic method
7
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Description
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HDL-C
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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Enzymatic method
8
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Description
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LDL-C
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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Freidewald formula
9
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Description
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Fasting blood sugar
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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Enzymatic method
10
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Description
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Insulin
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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ELISA
11
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Description
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Insulin resistance
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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formula
12
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Description
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Total antioxidant capacity
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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Spectrophotometry
13
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Description
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Malondialdehyde
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Timepoint
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Before the intervention and 8 weeks after starting
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Method of measurement
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Spectrophotometry
Secondary outcomes
1
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Description
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Anthropometric measurements (BMI, WHR, WC)
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Timepoint
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Baseline and 8 weeks after the intervention
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Method of measurement
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Secca scale, non stretch meter
2
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Description
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Energy and nutrient intake
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Timepoint
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Baseline and 8 weeks after the intervention
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Method of measurement
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24-hour dietary recall questionnaire for 3 days (two on week days and one on a weekend or holiday)
3
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Description
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Physical activity
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Timepoint
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Baseline and 8 weeks after the intervention
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Method of measurement
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International Assessment of Physical Activity (IPAQ) questionnaire
Intervention groups
1
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Description
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Intervention group: 500 mg/day curcumin of karen company (1 capsule of 500 mg) after lunch for 2 month
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Category
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Treatment - Drugs
2
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Description
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Control group: 500 mg/day placebo(1 capsule of 500mg containing starch flour) after lunch for 2 month
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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