In a period of 8 weeks, a randomized, double-blind clinical trial was carried out to compare the effects of carnitine and placebo on improving fatigue symptom in MS patients. Patients with relapsing-remitting MS, with Expanded Disability Status Scale (EDSS) less than 4.0, MS related fatigue with a Fatigue Severity Scale (FSS) >4, who had been receiving interferon β therapy for at least one year, were included. Patients with symptoms of depression, relapse within previous 8 weeks were excluded. Eligible patients were randomly assigned to one of two groups after obtaining written informed consent. one group received 1000mg/d carnitine and one group received placebo. A total of 66 patients were assessed at the beginning of the study and after 8 weeks using Fatigue Severity Scale (FSS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092010891N1
Registration date:2014-12-23, 1393/10/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-23, 1393/10/02
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 Neuroscience Research Center, Isfahan University of Medical Sciences
Expected recruitment start date
2011-06-01, 1390/03/11
Expected recruitment end date
2011-07-30, 1390/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of Carnitine with placebo for the Treatment of Fatigue in Patients with Multiple Sclerosis in a Randomized Double-blind Clinical Trial
Public title
Carnitine for the Treatment of Fatigue in Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: definite relapsing-remitting MS according to McDonald’s criteria؛ age between18 and 50 years; Expanded Disability Status Scale (EDSS) less than 4.0; MS related fatigue with a Fatigue Severity Scale (FSS)>4; receiving interferon β therapy for at least one year
Exclusion Criteria:
symptoms of depression (Beck Depression Criteria-pc>5); relapse within previous 8 weeks; had received corticosteroids within previous 8 weeks; had received medications affecting MS related fatigue
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
67
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
Isfahan, Hezarjrib St
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
389187
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
decrease of fatigue(FSS)
Timepoint
week 4 and 8
Method of measurement
FSS score
Secondary outcomes
1
Description
drug side effects
Timepoint
4,8 weeks
Method of measurement
recall
Intervention groups
1
Description
intervention group: carnitine 1000mg/d for 8 weeks (tab 500mg, bid)
Category
Treatment - Drugs
2
Description
control: placebo for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
fereshte ashtari
Street address
Kashani St., Kashani Hospital, MS clinic
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Payman Adibi
Street address
Hear Jerib st
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 Medical School
Full name of responsible person
Fereshteh Ashtari, Neurologist
Position
Professor
Other areas of specialty/work
Street address
Isfahan, Kashani Hospital
City
Isfahan
Postal code
Phone
+98 31 1235 0094
Fax
Email
f_ashtari@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Medical School
Full name of responsible person
Fereshteh Ashtari, Neurologist
Position
Professor
Other areas of specialty/work
Street address
Isfahan, Kashani Hospital
City
Isfahan
Postal code
Phone
+98 31 1235 9091
Fax
Email
f_ashtari@med.mui.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
Mojtaba Akbari
Position
Epidemioliogist
Other areas of specialty/work
Street address
Hezar Jerib Ave, Isfahan University of Medical Sciences,Medical Faculty
City
Esfahan
Postal code
0098311624977
Phone
+98 31 1624 9773
Fax
Email
akbarim@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)