Objectives: effect of high dose vitamin D3 intake vs placebo on interleukin-10, 17 and quality of life in Multiple Sclerosis patients
Design: randomized clinical trial
Study groups: intervention and placebo group
Phase:1 phase, 3 months
Sample size:40 for each group
Blinding: The patient and laboratory staff where the blood samples are obtained remain blinded throughout the study.
Randomization: Randomization is performed by selection from sealed envelopes.
Setting and conduct: After giving informed consent, eligible patients are randomized to one of two groups. The study physician gives medication or placebo to the participant according to randomization and allocation.
Participants including major eligibility criteria:
Inclusion criteria: a definite diagnosis of Relapsing-remitting MS (RRMS) according to Mc Donald criteria؛ age 18 to 55 years؛ EDSS (Expanded Disability Status Scale) score of less than 4؛ no relapse 30 days before inclusion؛ negative β-HCG test for women in child bearing age.
Exclusion criteria: pregnancy؛ lactation؛ any other disease than MS؛ receiving>4000IU/d vitamin D؛ past history of renal or hepatic disease؛ relapse during the study؛ received corticosteroids in the previous 30 days؛ Calcium (Ca)>11mg/dl؛ Aspartate Transaminase(AST) or Alanine Transaminase(ALT)>3 times normal values؛ alkaline phosphatase (ALP)>2.5 times normal values.
Intervention:One group receives 50,000IU vitamin D every five days (Vitamin D Pearl, 50,000IU, Zahravi pharmaceutical Co., Tabriz, Iran). The other group receives placebo.
main outcome measures:
primary outcome variables: Interleukin 10, 17
secondary outcome variables: quality of life
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010910891N2
Registration date:2015-08-19, 1394/05/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-19, 1394/05/28
Registrant information
Name
Fereshteh Ashtari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 913 114 7644
Email address
f_ashtari@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-05-15, 1393/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of high dose vitamin D3 intake on interleukin-10, 17 and quality of life in Multiple Sclerosis patients
Public title
Comparing the effect of high dose vitamin D3 intake on interleukin-10, 17 and quality of life in Multiple Sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a definite diagnosis of Relapsing-remitting Multiple Sclerosis (RRMS) according to Mc Donald criteria؛ age 18 to 55 years؛ EDSS (Expanded Disability Status Scale) score of less than 4؛ no relapse 30 days before inclusion؛ negative β-HCG test for women in child bearing age.
Exclusion criteria: pregnancy؛ lactation؛ any other disease than Multiple Sclerosis؛ receiving>4000IU/d vitamin D؛ past history of renal or hepatic disease؛ relapse during the study؛ received corticosteroids in the previous 30 days؛ Calcium (Ca)>11mg/dl؛ Aspartate Transaminase(AST) or Alanine Transaminase(ALT)>3 times normal values؛ alkaline phosphatase (ALP)>2.5 times normal values.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is performed by selection from sealed envelopes.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committee of Isfahan University of Medical Sciences
Street address
Hezar jerib Street, Azadi Square
City
Isfahan
Postal code
Approval date
2013-12-20, 1392/09/29
Ethics committee reference number
192165
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Primary outcomes
1
Description
Interleukin 10, 17
Timepoint
At baseline and after 3 months
Method of measurement
Blood sample
Secondary outcomes
1
Description
Quality of life
Timepoint
3 months
Method of measurement
MSQOL54
Intervention groups
1
Description
Intervention group 1:
50,000IU vitamin D
every five days,
for 3 months
vitamin D pearl
Zahravi Pharmaceuticals
Category
Treatment - Drugs
2
Description
Control group: placebo tablet,
including inert substance
one every five days,
made by a Pharmacist
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Fereshteh Ashtari
Street address
Beheshti Street, Kashani Hospital
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Payman Adibi
Street address
Hezar Jerib Street, Isfahan University of Medical Sciences
City
Isfahan
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, 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
Fereshteh Ashtari
Position
Professor in Neurology
Other areas of specialty/work
Street address
Kashani Hospital
City
Isfahan
Postal code
Phone
+98 31 3235 0001
Fax
Email
f_ashtari@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fereshteh Ashtari
Position
Professor in neurology
Other areas of specialty/work
Street address
Kashani hospital
City
Isfahan
Postal code
Phone
+32 350001
Fax
Email
f_ashtari.med.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Fereshteh Ashtari
Position
neurologist
Other areas of specialty/work
Street address
Kashani Hospital
City
Postal code
Phone
+98 31 3668 5555
Fax
Email
f_ashtari@med.mui.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)