Protocol summary
-
Study aim
-
The aim of this study is to determine the effects of combined omega-3 and vitamin D supplementation on clinical and metabolic status in patients with multiple sclerosis.
-
Design
-
Parallel double-blind (both patients and researchers) clinical trial.
-
Settings and conduct
-
Among patients with multiple sclerosis referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: Individuals aged 18-55 years diagnosed with multiple sclerosis will be included in this study.
Exclusion criteria: pregnancy or lactating during the past 6 mo, a history of nephrolithiasis during the previous 5 y, menopause, defined as no regular menstruation, and unwillingness to use appropriate contraception.
-
Intervention groups
-
Patients will be assigned into two groups to receive combined vitamin D and omega-3 (n=30) or placebo (n=30).
-
Main outcome variables
-
Expanded Disability Status Scale (EDSS) and inflammatory factors (primary outcomes) and markers of insulin metabolism, lipid profile and oxidative stress biomarkers (secondary outcomes)
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT2017090133941N20
Registration date:
2017-11-16, 1396/08/25
Registration timing:
retrospective
Last update:
2019-09-18, 1398/06/27
Update count:
1
-
Registration date
-
2017-11-16, 1396/08/25
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
Vice chancellor for research, Kashan University of Medical Sciences
-
Expected recruitment start date
-
2017-10-20, 1396/07/28
-
Expected recruitment end date
-
2017-11-05, 1396/08/14
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on clinical and metabolic status in patients with multiple sclerosis
-
Public title
-
Effect of combined omega-3 and vitamin D supplementation in treatment of multiple sclerosis
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients with multiple sclerosis
Aged 18-55 years
Course of disease relapsing–remitting MS (RRMS)
EDSS ≤4.5
Exclusion criteria:
Pregnancy
Lactating during the past 6 month
History of nephrolithiasis during the previous5 y
No regular menstruation
Menopause
Unwillingnessto use appropriate contraception
-
Age
-
From 18 years old to 55 years old
-
Gender
-
Both
-
Phase
-
2
-
Groups that have been masked
-
- Participant
- Investigator
- Outcome assessor
-
Sample size
-
Target sample size:
60
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either combined omega-3 and vitamin D supplementation (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-10-19, 1396/07/27
-
Ethics committee reference number
-
IR.KAUMS.MEDNT.REC.1396.64
Health conditions studied
1
-
Description of health condition studied
-
Multiple Sclerosis
-
ICD-10 code
-
G35
-
ICD-10 code description
-
Demyelinating disease of the central nervous system
Primary outcomes
1
-
Description
-
Expanded Disability Status Scale (EDSS)
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Physical examination by neurologist
2
-
Description
-
Hs-CRP
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa kit
3
-
Description
-
Nitric oxide
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
Secondary outcomes
1
-
Description
-
Malondialdehyde
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
2
-
Description
-
Glutathione
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
3
-
Description
-
Total antioxidant capacity
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Spectrophotometry
4
-
Description
-
Insulin
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa kit
5
-
Description
-
Insulin resistance
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Calculation using HOMA formula
6
-
Description
-
Total cholesterol
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
7
-
Description
-
Triglycerides
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
8
-
Description
-
HDL
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
9
-
Description
-
25-hydroxyvitamin D
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Elisa kit
10
-
Description
-
Fasting plasma glucose
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
11
-
Description
-
LDL-cholesterol
-
Timepoint
-
At the beginning of the study and after 12 weeks of intervention
-
Method of measurement
-
Enzymatic kit
Intervention groups
1
-
Description
-
Intervention group: 2000 mg omega-3 daily (NutMega, Australia) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 12 weeks orally.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 12 weeks orally.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kashan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available