We collect 10 milileters blood from patients for evaluation serum level of vitamin D3 and evaluate patients by Expanded Disability Status Scale (EDSS). Then patients in attack will receive pulse therapy for 5 days with methylprednisolone.After 8 weeks we check EDSS again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305281859N7
Registration date:2015-10-17, 1394/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-17, 1394/07/25
Registrant information
Name
Mohammad Ali Sahraian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8571
Email address
msahrai@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research ,Tehran University of Medical Sciences
Expected recruitment start date
2013-06-21, 1392/03/31
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of serum level of 25-hydroxy vitamin-D on Multiple Sclerosis attack under treatment with methyl prednisolone pulse on Sina Hospital
Public title
Relationship between serum level of vitamin-D3 and Expanded Disability Status Scale (EDSS) changes before and 8 weeks after methylprednisolone pulse therapy in multiple sclerosis (MS) patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- Patients with multiple sclerosis based on McDonalds Criteria. 2- Patients type relapsing-remitting (RRMS). 3-EDSS less than 5 before attack. 4-Less than 5 years after MS diagnosis. 5-Less than 5 attacks in the duration of MS diagnosis.
Exclusion criteria:
1- Association with any diseases such as liver diseases, renal diseases, bone marrow disfunction, sarcoidosis, renal stone,hypercalcemia. 2-pregnancy or breast feeding. 3-Using drugs such as hydrochlorothiazide, phenytoin, barbiturate, digital.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patients with serum level of vitamin D3 less than 30 nanogram per milliliter (ng/ml) will divided in to two groups with and without treatment by single dose injection of vitamin-D3 based on random numbers table. The patients with serum level of vitamin-D3 more than 30nanogram per milliliter (ng/ml) will not receive any treatment with vitamin-D3.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Vice chancellor for research ,Tehran University of Medical Sciences, Qods St, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.TUMS.REC.1394.823
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Disseminated Multiple Sclerosis
Primary outcomes
1
Description
The rate of recovery after attack
Timepoint
Before intervention and two months after intervention
Method of measurement
Physical examination done by neurologist and using Expanded Disability Status Scale (EDSS)
Secondary outcomes
1
Description
Expanded Disability Status Scale (EDSS)
Timepoint
Before intervention and two months after intervention
Method of measurement
Physical examination done by neurologist based on revised Mc-Donald (2010)
2
Description
serum level of 25-hydroxy vitamin-D3
Timepoint
Before intervention and two months after intervention
Method of measurement
Blood test
Intervention groups
1
Description
Amp vitamin-D3 ,chemical formulation active vitamin-D3 (calciteriol) , 300000 IU / day and single dose, intramuscular, made in Osva Pharmaceutical company in Islamic Republic Of Iran, not having generic name.
Category
Treatment - Drugs
2
Description
In 20 patients with low levels of vitamin D 3 whom are selected based on random numbers table , on the last day of 5 days pulse therapy , vitamin D 3 ampule will not be injected. They will be examined based on EDSS changes 8 weeks after pulse therapy.
Category
Treatment - Drugs
3
Description
In 20 patients with sufficient levels of vitamin D 3, therapy will not be given. They will be examined based on EDSS changes 8 weeks after pulse therapy.
Category
Treatment - Drugs
4
Description
In 20 patients with low levels of vitamin D 3 whom are selected based on random numbers table , on the last day of 5 days pulse therapy , vitamin D 3 ampule will be injected. They will be examined based on EDSS changes 8 weeks after pulse therapy.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sina Hospital, before Hasan abad Square , Imam Khomeini Street.
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. Masoud Yunesian
Street address
Vice chancellor for research ,Tehran University of Medical Sciences, Qods St, Keshavarz Blvd.
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
Sina Hospital
Full name of responsible person
Dr. Shadi Assefi
Position
MD, Resident of neurology
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Fax
Email
sh.assefi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr Mohammad Ali Sahraian
Position
Neurologist- MS Fellowship/Associate Professor
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Fax
Email
msahrai@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sina Hospital
Full name of responsible person
Dr. Rozita Doosti
Position
General Physician/Researcher
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini St.
City
Tehran
Postal code
1136746911
Phone
+98 21 6634 8571
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)