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Comparing the effects of β-D-Mannuronic acid with Placebo on disease activity and inflammatory markers in patients with Rheumatoid Arthritis

Protocol summary

Summary
The main target of this study is to assess the safety and efficacy of β-D-Mannuronic acid in patients suffering from Rheumatoid Arthritis. Β-D-Mannuronic acid which is an anti-inflammatory agent, is ranked in the family of nonsteroidal anti-inflammatory drugs. This agent has expressed qualified therapeutic effects with the greatest tolerability and safety in different experimental models like experimental model of Multiple schlerosis, Rheumatoid arthritis, nephrotic syndrome and acute glomerulonephritis. In this randomized controlled trial, 203 patients afflicted by Rheumatoid Arthritis, diagnosed based on the American College of Rheumatology (ACR) Diagnostic Criteria that have active disease, will be examined. Furthermore, these patients should not have other concomitant diseases such as Hepatic, renal, cardiovascular diseases or malignancies. Written informed consent will be signed by the patients. Then Patients will be randomly divided into two groups (Treatment and Control group). Treatment group (112 patients) will receive β-D-Mannuronic acid 1500 mg/day (three 500 mg tablets/day)with conventional immunosuppressive drugs and Control group (91 patients) ) will receive placebo with conventional immunosuppressive drugs orally for 12 weeks. Medical history and clinical parameters including the serum level of CRP, ESR, RF and Anti CCP will be evaluated at baseline and 12 weeks after treatment. The manner of blinding in this study is so neither participants in the study nor the persons who perform the test will be aware of the intervention. In order to allocate the patients randomly into two groups mentioned above, at first 29 blocks of 7 with C and T letters (The letters indicate the Treatment and Control groups) are created. 4 patients of each block belong to the treatment group and 3 patients belong to the control group. Then the blocks are randomly selected and arranged to reach a sequential combination of 203 letters. Each letter will be placed in a sealed packet according to the obtained sequence

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017100213739N10
Registration date: 2017-11-02, 1396/08/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-02, 1396/08/11
Registrant information
Name
Abbas Mirshafiey
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 4913
Email address
mirshafiey@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2017-10-16, 1396/07/24
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of β-D-Mannuronic acid with Placebo on disease activity and inflammatory markers in patients with Rheumatoid Arthritis
Public title
Evaluation of the therapeutic efficacy of Mannuronic Acid in Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: 1.Patients should be 18-65 year old, afflicted by Rheumatoid Arthritis, diagnosed based on the American College of Rheumatology (ACR) Diagnostic Criteria by a rheumatology specialist after evaluating the clinical parameters such as ESR, RF, CRP and Anti-CCP. 2.Each patient must sign written informed consent. 3.The disease in all patients should be in active form (DAS28>2.6) 4.None of patients must suffer from another concomitant diseases like Hepatic, renal, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral diseases. Exclusion Criteria: 1.History of fever and Infectious diseases, positive pregnancy test or lactation, other collagen- vascular diseases, other auto-immune diseases and Malignancies. 2.Enrolling in another clinical trial study within last 4 weeks 3.Suffering from other concomitant diseases such as hepatic, renal, hematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 203
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
In order to allocate the patients randomly into two groups of treatment and control, at first 29 blocks of 7 with C and T letters (The letters indicate the intervention and control groups) are created in each 4 patients are belonged to the intervention group and 3 patients are belonged to the control group). Then the blocks are randomly selected and arranged to obtain a sequential combination of 203 letters. Each letter will be placed in a sealed packet according to the obtained sequence.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences-Mashhad-Iran
City
Mashhad
Postal code
-
Approval date
2017-09-06, 1396/06/15
Ethics committee reference number
IR.MUMS.fm.REC.1396.309

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive Rheumatoid Arthritis

Primary outcomes

1

Description
Morning stiffness
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Taking history and Questionnaire

2

Description
The number of swollen joints
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Examination

3

Description
Pain
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Examination

4

Description
Severity of disease
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Taking history and Questionnaire

Secondary outcomes

1

Description
Serum level of CRP
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Turbidometry

2

Description
level of ٍُESR
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
See through Westergren method

3

Description
Anti-cyclic Citrullinated Peptide (anti-CCP) Antibodies
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
ELISA

4

Description
Rheumatoid factor (RF)
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
See through Agglutination

Intervention groups

1

Description
The Treatment group will receive β-D-Mannuronic acid 1500 mg/day (three oral 500 mg tablets/day) which is produced from the decomposition of Alginate powder (a safe and natural substance used in food and pharmaceutical industries) for 12 weeks. It should be mentioned that Alginate powder is purchased from Sigma Corporation of U.S.A and β-D-Mannuronic acid is produced from it's decomposition in central laboratory of immunology department at School of Public Health and Institute of Health Research affiliated by Tehran University of Medical Sciences.
Category
Treatment - Drugs

2

Description
The control group will receive orally 1500 mg/day (three 500 mg tablets/day) of plcebo for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology research center, Mashhad University of Medical Sciences
Full name of responsible person
Dr Zahra Rezaee Yazdi-Professor
Street address
Ghaem Hospital, Ahmad abad st, Doctor shariati sq
City
Mashhad

2

Recruitment center
Name of recruitment center
Rheumatology research center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Arman Ahmadzadeh-Assistant Professor
Street address
Loghman-e-Hakim Hospital, Makhsous st, Lashgar crossroad
City
Tehran

3

Recruitment center
Name of recruitment center
Rheumatology research center, Yazd University of Medical Sciences
Full name of responsible person
Dr Soleymani-Associate Professor
Street address
Shahid Sadooghi Hospital, Ebnesina st, Shahid Ghandi Boulevard
City
Yazd

4

Recruitment center
Name of recruitment center
Rheumatology research center, Eslam abad University of Medical Sciences
Full name of responsible person
Dr Abid farooghi-Professor
Street address
G8/3 sector, Loghman hakim st
City
Eslam abad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masood Younesian (MD, PhD, Vice-Chancellor for Research, Tehran University of Medical Sciences)
Street address
6th floor, central building of Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Tehran, Iran
City
Tehran
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, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Dr. Abbas Mirshafiey
Position
Immunology PHD, Master of Immunology department in public health school
Other areas of specialty/work
Street address
Department of Immunology, School of Public Health, Tehran University of Medical Sciences,16 Azar St ,Enghelab Sq, Tehran, Iran
City
Tehran
Postal code
-
Phone
+98 21 8895 4913
Fax
-
Email
mirshafiey@tums.ac.ir
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Dr. Abbas Mirshafiey
Position
Immunology PHD
Other areas of specialty/work
Street address
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences,16 Azar St ,Enghelab Sq, Tehran, Iran
City
Tehran
Postal code
-
Phone
+98 21 8895 4913
Fax
-
Email
mirshafiey@tums.ac.ir
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences
Full name of responsible person
Mona Aslani-Saeide Omidian
Position
Msc student in Immunology
Other areas of specialty/work
Street address
Department of Immunology, School of Public Health, Tehran University of Medical Sciences,16 Azar St ,Enghelab Sq, Tehran, Iran
City
Tehran
Postal code
-
Phone
+98 21 8895 4913
Fax
-
Email
monaaslani67@yahoo.com; saiedeomidian1@gmail.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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