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General information
empty
The updating process was done before publishing the paper to correct the registration information.
The updating process was done before publishing the paper to correct the registration information.
empty
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پروسه بروزرسانی قبل از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Kamal Esalatmanesh
Full name of responsible person - Persian: دکتر کمال اصالت منش
Position - English: Associate Professor
Position - Persian: دانشیار
Latest degree: sub_specialist
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 81 1518 7159
Mobile: +98 31 5546 3378
Fax:
Email: kamalesalatmanesh@kaums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Amirhossein Loghman
Full name of responsible person - Persian: امیر حسین لقمان
Position - English: Medical Student
Position - Persian: دانشجوی پزشکی
Latest degree: med_doctor
Area of specialty/work: 40
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ghotbe Ravandi Boulevard, Kashan
Street address - Persian: کاشان، بلوار قطب راوندی
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8115187159
Phone: +98 31 5554 0021
Mobile: +98 910 310 3082
Fax:
Email: amirhosseinloghman@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Kamal EsalatmaneshAmirhossein Loghman Full name of responsible person - Persian: دکتر کمال اصالت منشامیر حسین لقمان Position - English: Associate ProfessorMedical Student Position - Persian: دانشیاردانشجوی پزشکی Latest degree: submed_specialistdoctor Area of specialty/work: 40 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ghotbe Ravandi Boulevard, Kashan Street address - Persian: کاشان، بلوار قطب راوندی City - English: Kashan City - Persian: کاشان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8115187159 Phone: +98 81 1518 715931 5554 0021 Mobile: +98 31 5546 3378910 310 3082 Fax: Email: kamalesalatmaneshamirhosseinloghman@kaums.ac.irgmail.com Web page address:
Protocol summary
Study aim
Objective: The aim of this study is to determine the effects of melatonin supplementation on clinical status and metabolic profiles in patients with rheumatoid arthritis.
Design
Study design: randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplement (n=33) or placebo (n=33).
Settings and conduct
Among patients with rheumatoid arthritis referred to Beheshti Clinic, 66 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and end of the intervention. intervention: 12 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with rheumatoid arthritis.; aged 25 to 70 years. Exclusion criteria: Patients with infectious, malignant and other inflammatory diseases, those taking melatonin supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study, the night shift workers, subjects taking antibiotics medications, unwillingness to cooperate
Intervention groups
Intervention group: 6 mg/day Melatonin (Webber Naturals, Canada), one hour before bedtime for 12 weeks. Control group: Placebo (Barij Essence, Iran), one hour before bedtime for 12 weeks.
Main outcome variables
Outcomes: serum hs-CRP (primary outcome) and metabolic profiles, biomarkers of oxidative damage (secondary outcomes) will be quantified at study baseline and end-of-trial.
General information
Reason for update
The updating process was done before publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT20170513033941N67
Registration date:2019-11-30, 1398/09/09
Registration timing:registered_while_recruiting
Last update:2019-12-01, 1398/09/10
Update count:2
Registration date
2019-11-30, 1398/09/09
Registrant information
Name
Mohammadreza Sharif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5546 3378
Email address
ostadmohammadi-vr@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effects of melatonin supplementation on clinical status and metabolic profiles in patients with rheumatoid arthritis
Public title
The effects of melatonin supplementation in the treatment of rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with rheumatoid arthritis
Individuals aged 25-70 years old
Exclusion criteria:
Patients with infectious, malignant and other inflammatory diseases
those taking melatonin supplements, antioxidant and/or anti-inflammatory supplements within 3 months prior to enrollment in the study
the night shift workers
subjects taking antibiotics medications
unwillingness to cooperate
Age
From 25 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 66 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes. Supplements and placebos are in the same packaging at the Pharmaceutical company. Only the code is written on the packages. Patients and researchers do not know the type of intervention and after analyzing the data, packet codes are decoded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2019-10-21, 1398/07/29
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.078
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
Hs-CRP
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
Malondialdehyde
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
3
Description
Total antioxidant capacity
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Spectrophotometry
4
Description
Triglycerides
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
5
Description
Total cholesterol
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
6
Description
HDL
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
7
Description
Insulin
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Elisa kit
8
Description
Insulin resistance
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Calculation using HOMA formula
9
Description
Fasting plasma glucose
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
Enzymatic kit
Intervention groups
1
Description
Intervention group: 6 mg/day Melatonin (Webber Naturals, Canada), one hour before bedtime for 12 weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo (Barij Essence, Iran), one hour before bedtime for 12 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Clinic
Full name of responsible person
Dr. Kamal Esalatmanesh
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
kamalesalatmanesh@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafsheh
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
banafsheh.hr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Amirhossein Loghman
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5554 0021
Email
amirhosseinloghman@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Kamal Esalatmanesh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
kamalesalatmanesh@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Kamal Esalatmanesh
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
kamalesalatmanesh@kaums.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