Effects of adjunct low-dose vitamin D on relapsing-remitting multiple sclerosis progression: Preliminary findings of a randomized, placebo-controlled trial
The aim of this preliminary study is to evaluate the effect of low-dose oral vitamin D in combination with current disease modifying therapy on the prevention of progression of relapsing-remitting multiple sclerosis (RRMS). A phase II double-blind placebo-controlled randomized clinical trial will be conducted between October 200 and October 2011 included 50 patients with confirmed RRMS aged 25 to 57 years and normal serum 25-hydroxyvitamin D. The patients will be randomly allocated to receive 12-months of treatment with either escalating calcitriol doses up to 0.5 µg/day or placebo combined with disease-modifying therapy. Response to treatment will be assessed at eight week intervals. Primary and secondary outcome measures are number of relapse and changes in mean Expanded Disability Status Scale (EDSS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104166202N1
Registration date:2011-04-29, 1390/02/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-29, 1390/02/09
Registrant information
Name
Mohsen Janghorbani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1233 4893
Email address
janghorbani@hlth.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2009-04-01, 1388/01/12
Expected recruitment end date
2011-06-01, 1390/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of adjunct low-dose vitamin D on relapsing-remitting multiple sclerosis progression: Preliminary findings of a randomized, placebo-controlled trial
Public title
Effects of adjunct low-dose vitamin D on relapsing-remitting multiple sclerosis progression: Preliminary findings of a randomized, placebo-controlled trial
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: either sex, age between 15 and 60 years, diagnosis of definite RRMS with a MRI, clinical or laboratory, mean (standard deviation) duration equal to 4.3 (2.2) years, range 1-12 years, stable neurological functioning for at least one month prior to the study entry, EDSS score ≤6, serum 25-hydroxyvitamin D level> 40 ng/ml, willingness to continue current medications for the duration of the study
Exclusion criteria: evidence of substantial abnormalities in neurological, psychiatric, cardiac, endocrinological, hematologic, hepatic, renal, or metabolic functions, use of digitalis, vitamin D supplement, any condition predisposing to hypercalcemia, nephrolithiasis, renal insufficiency, pregnancy as determined by history, physical examination and screening blood tests. secondary-progressive and primary-progressive MS, Women in child-bearing age with no clinically-accepted method of contraception
Age
From 15 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
School of Public Health, Isfahan University of Medical Sciences
City
Isfahan
Postal code
8144503500
Approval date
2008-06-07, 1387/03/18
Ethics committee reference number
386369
Health conditions studied
1
Description of health condition studied
relapsing-remitting multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Expanded Disability Status Scale (EDSS).
Timepoint
2-months interval, at the baseline and months 2, 4, 6, 8, 10 and 12
Method of measurement
Clinical evaluation by a qualified neurologist.
Secondary outcomes
1
Description
Number of relapses
Timepoint
2-months interval, at the baseline and months 2, 4, 6, 8, 10 and 12
Method of measurement
Clinical evaluation by a qualified neurologist.
Intervention groups
1
Description
Adjunct Calcitriol, (Trade name Zavitrol, Zahravi Pharm. Co. Tabriz, Iran), 0.25 µg per day (twice a day, orally before meals), increased to 0.5 µg/day after 2 weeks and will continue for 12- months as well as routine MS medications.
Category
Treatment - Drugs
2
Description
Placebo capsules, twice a day, orally before meals for 12-months as well as routine MS medications.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Neurosciences Research Center
Full name of responsible person
Mohsen Janghorbani and Vahid Shaygannejad
Street address
School of Public Health, Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Vahid Shatgannejad
Street address
Dept. of Neurology, Alzahrz Hospital
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Janghorbani
Position
Prof.
Other areas of specialty/work
Street address
School of Public Health, Isfahan University of Medical Sciences