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Survey the effect of melatonin supplementation on clinical symptoms and sleep quality in patients with rheumatoid arthritis

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History
# Registration date Revision Id
2 2021-11-19, 1400/08/28 208477
1 2020-08-15, 1399/05/25 147234
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  • Protocol summary

    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
    The aim of this study is to determine the effects of melatonin supplementation on clinical status and sleep quality in patients with rheumatoid arthritis.
    هدف این مطالعه تعیین اثرات مکمل ملاتونین بر علایم بالینی، کیفیت خواب، سطح سرمی TAC و MMP1 در بیماران مبتلا به آرتریت روماتوئید است.
    هدف این مطالعه تعیین اثرات مکمل ملاتونین بر علایم بالینی و کیفیت خواب در بیماران مبتلا به آرتریت روماتوئید است.
    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.
    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. intervention: 8 weeks.
    از بین بیماران مبتلا به آرتریت روماتوئید ارجاع شده به مطب فوق تخصص روماتولوژی، 70 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. نمونه خون ناشتا در ابتدای مطالعه و پایان مداخله از بیماران گرفته خواهد شد. زمان مداخله: 8 هفته.
    از بین بیماران مبتلا به آرتریت روماتوئید ارجاع شده به مطب فوق تخصص روماتولوژی، 70 بیمار بر اساس معیار های ورود و خروج از مطالعه انتخاب خواهند شد. شرکت کنندگان و هم محققان یا ارزیابان پیامد از تخصیص گروههای مطالعه بی اطلاعند. کپسول های مکمل و پلاسبو از نظر شکل و اندازه مشابه هستند. زمان مداخله: 8 هفته.
    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.
    sleep quality, pain intensity, and disease severity (primary outcome) will be quantified at study baseline and end-of-trial.
    سطح سرمی TAC و MMP1 (پیامد اولیه) و کیفیت خواب، شدت درد و شدت بیماری (پیامد ثانویه) در ابتدا و انتها مداخله اندازه گیری خواهد شد.
    کیفیت خواب، شدت درد و شدت بیماری (پیامد اولیه) در ابتدا و انتها مداخله اندازه گیری خواهد شد.

  • General information

    Other
    Parallel
    empty
    Due to the widespread prevalence of Covid19 disease in Ahvaz and the lack of cooperation of patients to receive blood samples and perform laboratory tests, as well as other problems that arose in this direction, it was decided to exclude laboratory tests from the study.
    empty
    به دلیل شیوع گسترده بیماری کووید ۱۹ در شهر اهواز و عدم همکاری بیماران جهت دریافت نمونه خون و انجام تست های آزمایشگاهی و همچنین مشکلات دیگری که در این مسیر به وجود آمد تصمیم بر آن شد که تست های آزمایشگاهی از مطالعه حذف شوند.
    Survey the effect of melatonin supplementation on clinical symptoms, sleep quality, serum levels of TAC and MMP1 in patients with rheumatoid arthritis
    Survey the effect of melatonin supplementation on clinical symptoms and sleep quality in patients with rheumatoid arthritis
    بررسی اثر مصرف مکمل ملاتونین بر علائم بالینی، کیفیت خواب، سطح سرمی TAC و MMP1 در بیماران مبتلا به آرتریت روماتوئید
    بررسی اثر مصرف مکمل ملاتونین بر علایم بالینی و کیفیت خواب در بیماران مبتلا به آرتریت روماتویید

  • Primary outcomes

    #1
    Serum levels of TAC
    Sleep quality
    میزان TAC سرم
    کیفیت خواب
    Using the kit by TAC method
    Questionnaire
    با استفاده از کیت به روش TAC
    پرسشنامه
    #2
    Serum levels of MMP1
    Intensity of pain
    میزان MMP1 سرم
    شدت درد
    ELISA
    VAS Questionnaire
    الایزا
    پرسشنامه VAS
    #3
    empty
    Illness severity
    empty
    شدت بیماری
    empty
    Before and after the intervention
    empty
    قبل و بعد از مداخله
    empty
    DAS-28 Questionnaire
    empty
    پرسشنامه DAS-28

  • Secondary outcomes

    #1
    Sleep quality
    empty
    کیفیت خواب
    empty
    Before and after the intervention
    empty
    قبل و بعد از مداخله
    empty
    Questionnaire
    empty
    پرسشنامه
    empty
    #2
    Intensity of pain
    empty
    شدت درد
    empty
    Before and after the intervention
    empty
    قبل و بعد از مداخله
    empty
    VAS Questionnaire
    empty
    پرسشنامه VAS
    empty
    #3
    Illness severity
    empty
    شدت بیماری
    empty
    Before and after the intervention
    empty
    قبل و بعد از مداخله
    empty
    DAS-28 Questionnaire
    empty
    پرسشنامه DAS-28
    empty

Protocol summary

Study aim
The aim of this study is to determine the effects of melatonin supplementation on clinical status and sleep quality 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. 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
sleep quality, pain intensity, and disease severity (primary outcome) will be quantified at study baseline and end-of-trial.

General information

Reason for update
Due to the widespread prevalence of Covid19 disease in Ahvaz and the lack of cooperation of patients to receive blood samples and perform laboratory tests, as well as other problems that arose in this direction, it was decided to exclude laboratory tests from the study.
Acronym
IRCT registration information
IRCT registration number: IRCT20191231045964N1
Registration date: 2020-08-15, 1399/05/25
Registration timing: retrospective

Last update: 2021-12-08, 1400/09/17
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 and sleep quality 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
Parallel
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
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

Secondary outcomes

empty

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
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