Objective: effect of multivitamin-mineral on fatigue and inflammatory cytokines in multiple sclerosis patients
Study Design: This study is a 3 blind randomized and interventional study.
The study population and sample size: 100 multiple sclerosis patients participate in the study that are referred from multiple sclerosis clinics of ICNR and MS Sinai Research Center (joint project between two centers).
Groups: 2 groups; 50 multiple sclerosis patients enter to interventional group and 50 multiple sclerosis patients enter to placebo group. Patients in intervention group are received Multivitamin Mineral for 3 months in manner of 2 tablets per day and Patients in control group are received placebo (microcrystalin cellulose + croscarmellose sodium) for 3 months in manner of 2 tablets per day
Main inclusion criteria: Patients with Relapsing Remitting Multiple Sclerosis (RRMS); Patients must be at range of 18-45 years old; Patients should take every types of interferon for at least 3 months before the study; patients EDSS must be 0-6
Main exclusion criteria: abnormal serum ferritin, serum zinc, vitamin D / Patients with increasing in EDSS more than 1 unit during the study. The primary outcomes are fatigue and inflammatory and non-inflammatory cytokines serum levels and consequences outcome is depression.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022026658N1
Registration date:2016-02-29, 1394/12/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-29, 1394/12/10
Registrant information
Name
Sama Bitarafan
Name of organization / entity
Iranian Center of Neurological Research/ Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 8899
Email address
bitarafan@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Cinnagen pharmaceutical companies
(Related academic research with industry)
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of "evidence based formulated multivitamin-mineral” supplementation on fatigue scale and serum level cytokines in multiple sclerosis
Public title
Impact of multivitamin on fatigue and inflammatory cytokines in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with definite diagnosis of multiple sclerosis according to McDonald (2010) criteria; Patients with Relapsing Remitting Multiple Sclerosis (RRMS) as the clinical course of disease; Patients must be at range of 18-45 years old; Patients should take every types of interferon for at least 3 months before the study; Patients should not take any supplements from at least 3 months before the study; The fatigue score of patients must be 21-84 based on MFIS questionnaire; Patients should not take any antidepressant SSRI, modafinil, bupropion and Amurel at least 3 months before the study. patients EDSS must be 0-6
Exclusion criteria:
Patients with definite diagnosis of severe liver disease, gallstones and pancreatitis, systemic diseases affecting the balance of Th1 / Th2 such as asthma and active viral disease, autoimmune diseases such as SLE and RA,inflammatory bowel disease, type I diabetes; Patients with abnormal result tests of serum ferritin, serum zinc, vitamin D; Patients with malnutrition (BMI less than 19) or obesity (BMI greater than 25); Patients with changes in drugs and diet during the study; ); Patients with known allergic reactions to vitamin supplements; Patients with Pregnancy; Patients with alcohol or drug addiction and Smoking; Patients that forget to use of more than 12 days of supplements (10% of supplementation); Patients with increasing in EDSS more than 1 unit during the study.
Age
From 77 years old to 49 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Central Building of Tehran University
City
Tehran
Postal code
(021) 88925072
Approval date
2015-10-04, 1394/07/12
Ethics committee reference number
شماره طرح: 27795 /شماره نامه:IR.TUMS.REC.1394.873
Health conditions studied
1
Description of health condition studied
Demyelinating diseases of the central nervous system
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
IL 17
Timepoint
At first and end of study
Method of measurement
laboratory
2
Description
IF gama
Timepoint
At first and end of study
Method of measurement
laboratory
3
Description
CRP
Timepoint
At first and end of study
Method of measurement
laboratory
4
Description
Fatigue
Timepoint
At first and end of study
Method of measurement
MFIS, ESS Questionnaire
5
Description
IL 10
Timepoint
At first and end of study
Method of measurement
laboratory
Secondary outcomes
1
Description
Depression
Timepoint
At first and end of study
Method of measurement
Beck II questionnare
Intervention groups
1
Description
Multivitamin-mineral supplementation in intervention group
Category
Treatment - Other
2
Description
Administration of placebo with the same shape and packaging in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Center of Neurological Research
Full name of responsible person
Dr Sama Bitarafan
Street address
Imam Khomeini Hospital, Iranian Center of Neurological Research
City
Tehran
2
Recruitment center
Name of recruitment center
Sina MS research center
Full name of responsible person
Dr Sama Bitarafan
Street address
Sinai Hospital/ Sina MS research center
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sinagene Pharmaceutical Company/ Nano Hayat Daru
Full name of responsible person
Dr Behzad Taghipour
Street address
Pardis Technology Park/ 16 Avenue/ 168/2
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sinagene Pharmaceutical Company/ Nano Hayat Daru
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
Iranian Center of Neurological Research
Full name of responsible person
Dr Sama Bitarafan
Position
Assistant Professor
Other areas of specialty/work
Street address
Immam Khomeini Hospital/Iranian Center of Neurological Research
City
Tehran
Postal code
Phone
+98 21 6694 8899
Fax
+98 66581558
Email
Bitarafans@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Center of Neurological Research
Full name of responsible person
Dr Sama Bitarafan
Position
Assistant Professor
Other areas of specialty/work
Street address
Immam Khomeini Hospital/Iranian Center of Neurological Research
City
Tehran
Postal code
Phone
+98 21 6694 8899
Fax
Email
Bitarafans@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian Center of Neurological Research
Full name of responsible person
Dr Sama Bitarafan
Position
Assistant Professor
Other areas of specialty/work
Street address
Immam Khomeini Hospital/Iranian Center of Neurological Research
City
Tehrasn
Postal code
Phone
+98 21 6694 8899
Fax
Email
Bitarafans@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)