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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
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
1
-
Sponsor
-
-
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
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