The aim of this study is to determine the effects of melatonin supplementation on clinical status, sleep quality, serum levels of TAC and MMP1 in patients with rheumatoid arthritis
Design
Randomized double-blind placebo-controlled trial. Patients will be assigned into two groups to receive melatonin supplement (n=35) or placebo (n=35).
Settings and conduct
Among patients with rheumatoid arthritis referred to rheumatology specialist office , 70 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: 8 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with rheumatoid arthritis.; aged 18 to 50 years; BMI 18/5 to 30; Exclusion criteria: Patients unwilling to continue the study, people taking antidepressants, sedatives such as sertraline and fluoxetine, people smoking and alcohol, use of antioxidant supplements in the last 3 months, people taking anticoagulants, pregnancy and Breastfeeding (women) and any disease other than rheumatoid arthritis
Intervention groups
Intervention group: 3 mg/day Melatonin (Norm life, Iran), one hour before bedtime for 8 weeks. Control group: Placebo, one hour before bedtime for 8 weeks.
Main outcome variables
serum levels of TAC and MMP1 (primary outcome) and sleep quality, pain intensity, and disease severity (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191231045964N1
Registration date:2020-08-15, 1399/05/25
Registration timing:retrospective
Last update:2020-08-15, 1399/05/25
Update count:1
Registration date
2020-08-15, 1399/05/25
Registrant information
Name
Tayebeh Palimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 5234 4108
Email address
palimitayebeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of melatonin supplementation on clinical symptoms, sleep quality, serum levels of TAC and MMP1 in patients with rheumatoid arthritis
Public title
Melatonin in rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
They are eighteen to fifty years old
Patients are selected from both sexes
Patients with rheumatoid arthritis
Patients' body mass index is between 18/5_30
Exclusion criteria:
People taking antidepressants and sedatives
People who use alcohol and cigarettes
Taking antioxidant supplements within 3 months prior
People taking anticoagulants
Pregnant and lactating women
Any disease except rheumatoid arthritis
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization technique with 1:1 ratio will be used to achieve balanced group sizes. Supplements and placebos are in the same packaging. 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
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.AJUMS.REC.1398.812
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 levels of TAC
Timepoint
Before and after the intervention
Method of measurement
Using the kit by TAC method
2
Description
Serum levels of MMP1
Timepoint
Before and after the intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Sleep quality
Timepoint
Before and after the intervention
Method of measurement
Questionnaire
2
Description
Intensity of pain
Timepoint
Before and after the intervention
Method of measurement
VAS Questionnaire
3
Description
Illness severity
Timepoint
Before and after the intervention
Method of measurement
DAS-28 Questionnaire
Intervention groups
1
Description
Intervention group: One 3 mg melatonin capsule, daily, for 2 months
Category
Treatment - Drugs
2
Description
Control group: One 3 mg placebo capsule, daily, for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Specialist Office
Full name of responsible person
Dr. Majid Karandish
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan street, Ahvaz, Khosetan,Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8253
Email
palimitayebeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badawi
Street address
Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Fax
+98 61 3336 2414
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Tayebeh Palimi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Para-Medical School, Ahvaz Jundishapur University of Medical Sciences,Golestan highway
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
palimitayebeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Majid Karandish
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8317
Email
mkarandish@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Tayebeh Palimi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition Department, Para-Medical School, Ahvaz Jundishapur University of Medical Sciences,Golestan highway
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Phone
006133738383
Email
palimitayebeh@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