A study on nutritional status of riboflavin and the effect of riboflavin supplementation on disability and quality of life scores in patients with multiple sclerosis
This is a randomized double blind control trial on 30 patients with multiple sclerosis (MS) introduced to Khuzestan MS society. The aim of this study is the survey of nutritional status of riboflavin and the effect of riboflavin supplementation on disability and quality of life in patients with MS. Inclusion criteria: 1. Tha approvment of MS disease by MS committee, 2. the age between 18-50 years old, 3. the patient should not decide to change or start disease regulation or symptomatic treatments, 4. using brrietric trice for females in productivity age. exclusion criteria: 1. gestation, 2. intake other vitmins contemporary with riboflavin, 3. contributing in another trials contemporary, 4. the ages under 18 and upper 50 years old. Bloods will obtain for evaluating riboflavin status, measuring serum homosystein levels and determining blood group after categorizing patients randomly in two groups (intervention and control). Intervention and control groups will receive 10 milligram per day riboflavin capsule and placebo for 6 mounts, respectively. Primary outcome is improving nutritional riboflavin status and lowering serum homosystein levels. Independent sample t-test, logistic regression and nonparametric analysis will use to compare qualitative data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102175855N1
Registration date:2011-04-11, 1390/01/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-11, 1390/01/22
Registrant information
Name
Mahshid Naghashpour
Name of organization / entity
ACECR-Khuzestan
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 0023
Email address
naghashpour@acecr.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University of Medical Sciences/ Khuzestan Jahaddaneshgahi ( ACECR-Khuzestan)
Expected recruitment start date
2010-10-18, 1389/07/26
Expected recruitment end date
2011-02-09, 1389/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on nutritional status of riboflavin and the effect of riboflavin supplementation on disability and quality of life scores in patients with multiple sclerosis
Public title
Riboflavin and multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Tha approvment of MS disease by MS committee, 2. the age between 18-50 years old, 3. the patient should not decide to change or start disease regulation or symptomatic treatments, 4. using brrietric trice for females in productivity age. exclusion criteria: 1. gestation, 2. intake other vitmins contemporary with riboflavin, 3. contributing in another trials contemporary, 4. the ages under 18 and upper 50 years old.
Age
From 18 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features
We will obtain 5 ML blood for measuring erythrocyte glutathione reductase activity coefficients in fasting. Also, intervention and control groups will obtain riboflavin supplementation (10 mg) and placebo for 24 weeks. Neither patient nor researcher don’t informed about which patient set in which group until complete study. Patients will continue their medications. Patients in two groups will complete MSQOL54 questionnaire in the first, sixth and twelfth weeks of study and physician will measured their EDSS. Also 5 ML blood will be obtained for measuring erythrocyte glutathione reductase activity coefficients in fasting in the twelfth week. The score of MSQOL54 questionnaire alternatives which be answered by patients will change to numbers between 0 to 100 and will categorize as percent. Higher score illustrates the better patient life style independent to health.