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Effects of melatonin supplementation on clinical symptoms, disease activity and serum oxidative factors in patients with systemic lupus erythematosus

Protocol summary

Study aim
Effects of melatonin supplementation on clinical symptoms, disease activity and serum oxidative factors in patients with systemic lupus erythematosus
Design
This study is a randomized double-blind clinical trial carried out in lupus patients referred to the rheumatology clinic of Tabriz University of Medical Sciences. 50 lupus patients are allocated randomly to two groups receiving melatonin (10 mg divided in to two 5 mg) and recieving placebo.
Settings and conduct
rheumatology clinic of Tabriz University o Medical Sciences- patients and main researcher will be blind
Participants/Inclusion and exclusion criteria
patients with systemic lupus erythematosus. Inclusion criteria: having systemic lupus erythematosus accroding to ACR criteria and rheumatologist diagnosis; eager to participate in study. Exclusion criteria: having other autoimmune diseases, uncontrolled hypertention, diabetes and other endocrine disorders, cardiovascular diseases, chronic renal failure, liver dysfunction, depression, proliferative lupus nephritis, brain involvement, lupus vasculitis, peritonitis, thrombotic thrombocytopenia purpura, severe hemolysis with reticulocyte more than 8%, severe thrombocytopenia (platelet below 40000), ucarditis, endocarditis, lupus pneumonia, alveolar hemorrhage, use of sedations and contraceptives, use of antioxidant and w3 supplements in previous month, smoking and alcohol consumption, allergy to melatonin, pregnancy and lactation.
Intervention groups
Patients were allocated in to intervention group (receiving melatonin 10mg/day) and control group (receiving placebo).
Main outcome variables
Before and after intervention, clinical symptoms are assessed with physical examination and disease activity is assessed with SLEDAI. Serum total antioxidant capacity and malondialdehyde are assessed with kit.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110708006975N6
Registration date: 2018-08-24, 1397/06/02
Registration timing: prospective

Last update: 2018-08-24, 1397/06/02
Update count: 0
Registration date
2018-08-24, 1397/06/02
Registrant information
Name
Alireza Khabbazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3966
Email address
khabbazia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of melatonin supplementation on clinical symptoms, disease activity and serum oxidative factors in patients with systemic lupus erythematosus
Public title
Effects of melatonin in systemic lupus erythematosus
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having systemic lupus erythematosus according to ACR criteria and rheumatologist diagnosis Eager to participate in study
Exclusion criteria:
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
permuted block randomization using RAS software
Blinding (investigator's opinion)
Double blinded
Blinding description
participants ;main researcher .
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Approval date
2018-07-23, 1397/05/01
Ethics committee reference number
IR.TBZMED.REC.1397.349

Health conditions studied

1

Description of health condition studied
systemic lupus erythematosus
ICD-10 code
M32
ICD-10 code description
Systemic lupus erythematosus (SLE)

Primary outcomes

1

Description
clinical symptoms
Timepoint
before and after intervention
Method of measurement
physician examination

2

Description
disease activity
Timepoint
before and after intervention
Method of measurement
SLEDAI questionnaire

3

Description
Total antioxidant capacity
Timepoint
before and after intervention
Method of measurement
kit

4

Description
malondialdehyde
Timepoint
before and after intervention
Method of measurement
florimetry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Other

2

Description
Control group:
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Emamreza Hospital
Full name of responsible person
Mahammadmahdi Nabatian
Street address
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3336 9331
Email
mahdi_6684@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Connective Tissue Diseases Research Center, Tabriz Unversity of Medical Sciences
Full name of responsible person
Alireza Khabbazi
Street address
Emamreza hospital, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3336 9331
Email
khabbazia@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Connective Tissue Diseases Research Center, Tabriz Unversity 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
Connective Tissue Diseases Research center, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Khabbazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Emamreza Hospital, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3336 9331
Email
khabbazia@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Khabbazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Emamreza Hospital, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3336 9331
Email
khabbazia@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Connective Tissue Diseases Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Khabbazi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Emamreza Hospital- Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3336 9331
Email
khabbazia@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Abuse is possible.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
The data file will be provided after encoding.
When the data will become available and for how long
6 months after printing results.
To whom data/document is available
all persons
Under which criteria data/document could be used
Use is not allowed.
From where data/document is obtainable
Alireza Khabbazi
What processes are involved for a request to access data/document
Send request via email and receive
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