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A randomized controlled trial comparing the effects of β-D-Mannuronic acid and conventional Non-steroidal anti-inflammatory drugs on disease activity and inflammatory markers in patients with ankylosing spondylitis

Protocol summary

Summary
The aim of this study is to assess the safety and effectiveness of β-D mannuronic acid in patients with Ankylosing spondylitis. β-D mannuronic acid has shown therapeutic effects with the greatest tolerability and safety in various experimental models such as experimental autoimmune encephalitis, adjuvant induced arthritis, nephrotic syndrome and acute glomerulonephritis. In this randomized, controlled trial, thirty five patients with Ankylosing spondylitis fulfilling the modified New York criteria that have active disease (BASDAI score ≥ 4 and BASFI score ≥ 4) will be examined. Additionally, patients do not have other concomitant diseases (Hepatic, renal and cardiovascular) or malignancies. Written informed consent will be obtained. Patients will be randomly assigned to receive either β-D mannuronic acid (treatment group, 25 patients) 1500 mg/day (three 500 mg tablets/day) or conventional Non-steroidal anti-inflammatory drugs (control group, 10 patients) orally for 12 weeks. Medical history, physical examinations, BASDAI and BASFI scores, serum level of CRP, the frequencies of circulating Th17 cells and regulatory T cells, L- selectin expression and leukocyte function-associated antigen-1 (LFA-1) expression will be evaluated at baseline and 12 weeks after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013062213739N1
Registration date: 2013-12-30, 1392/10/09
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-12-30, 1392/10/09
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
1- Vice-Chancellor for Research, Tehran University of Medical Sciences2- Rheumatology research center, Tehran University of Medical Sciences3- Research Center for Immunodeficiencies, Children’s Medical Center, Tehran University of Medical Sciences
Expected recruitment start date
2014-04-20, 1393/01/31
Expected recruitment end date
2015-04-20, 1394/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial comparing the effects of β-D-Mannuronic acid and conventional Non-steroidal anti-inflammatory drugs on disease activity and inflammatory markers in patients with ankylosing spondylitis
Public title
The therapeutic effects of β-D-Mannuronic acid in patients with ankylosing spondylitis
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion Criteria: Patients age 18-45 years old, Diagnosis of "Definite AS" as defined by the modified New York criteria, Disease activity equal to BASDAI score ≥ 4, Functional activity equal to BASFI score ≥ 4, Each patient must sign written informed consent. Exclusion Criteria: History of fever and Infectious diseases, Positive pregnancy test or Lactation, Other collagen- vascular diseases, Other auto-immune diseases, Malignancies, Patients have enrolled another clinical trial study within last 4 weeks, Other concomitant diseases (Hepatic, renal, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease)
Age
From 18 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
1- In this study the patients and outcomes assessor do not know which β-D mannuronic acid or conventional Non-steroidal anti-inflammatory drugs is being given (double-blind). 2- In this study randomization will be performed by stratified randomization method. 3- β-D mannuronic acid was extracted from Alginic acid sodium salt (Sigma, A2033-1Kg) as a reference sample. This extraction method is a modified procedure of acid hydrolysis method (Chhatbar et al. 2009) that is being performed in Immunology division of Department of pathobiology, School of Public Health, Tehran University of Medical Sciences.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
6th floor, Headquarter for Tehran University of Medical Sciences, On the Corner of Keshavarz Blvd. and Qods Street, Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2013-10-12, 1392/07/20
Ethics committee reference number
130.1525.ص.92

Health conditions studied

1

Description of health condition studied
Ankylosing spondylitis
ICD-10 code
M45
ICD-10 code description
Ankylosing spondylitis

Primary outcomes

1

Description
The ASAS20 response criteria
Timepoint
12 weeks after intervention (at the end of study)
Method of measurement
Questionnaire

2

Description
Disease activity
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Questionnaire

3

Description
Physical function
Timepoint
At baseline and after 12 weeks of treatment.
Method of measurement
Questionnaire

Secondary outcomes

1

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

2

Description
The frequency of circulating Th17 cells
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
flow cytometry

3

Description
The frequency of circulating regulatory T (Treg) cells
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
flow cytometry

4

Description
L- selectin expression
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
flow cytometry

5

Description
LFA-1 expression
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Real-time PCR

6

Description
Serum level of IL-6
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Elisa

7

Description
Serum level of IL-10
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Elisa

8

Description
Serum level of IL-17A
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Elisa

9

Description
Serum level of TNF-α
Timepoint
At baseline and after 12 weeks of treatment
Method of measurement
Elisa

Intervention groups

1

Description
Treatment group will receive 1500 mg/day (three 500 mg tablets/day) of β-D mannuronic acid orally for 12 weeks.
Category
Treatment - Drugs

2

Description
Control group will receive conventional Non-steroidal anti-inflammatory drugs orally for 12 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rheumatology research center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mahdi mahmoudi (PhD- Assistant Professor)
Street address
Rheumatology research center, Dr. Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran

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, Headquarter for 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
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

2

Sponsor
Name of organization / entity
Rheumatology research center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Ahmad reza Jamshidi (MD, Professor)
Street address
Rheumatology research center, Dr. Shariati Hospital, Tehran University of Medical Sciences, 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
Rheumatology research center, Tehran University of Medical Sciences
Proportion provided by this source
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

3

Sponsor
Name of organization / entity
Research Center for Immunodeficiencies, Tehran University of Medical Sciences
Full name of responsible person
Dr. Asghar Agha Mohammadi (MD, Professor)
Street address
Research Center for Immunodeficiencies, Children’s Medical Center, Tehran University of Medical Sciences, 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
Research Center for Immunodeficiencies, Tehran University of Medical Sciences
Proportion provided by this source
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
Head of the Department of pathobiology (PHD - Professor)
Other areas of specialty/work
Street address
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences, 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
Head of the Department of pathobiology (PhD - Professor)
Other areas of specialty/work
Street address
Department of pathobiology, School of Public Health, Tehran University of Medical Sciences, 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

Sharing plan

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