Comparison of the average scores of the disease activity/quality of life/fatigue questionnaire between 2 groups receiving 1, B6, B12B and magnesium supplements and placebo between the two groups and within each group at the beginning and end.
Design
The intervention will be done in a randomized block method and double-blind on 98 patients
Settings and conduct
The study is conducted in a double-blind way in a specialized clinic for digestive and liver diseases.The duration of the intervention is 4 weeks in the form of Neurobion and magnesium supplementation or placebo. The dosage of the supplement includes 100 mg of vitamin B1, 100 mg of vitamin B6, 200 micrograms of vitamin B12 and 250 mg of magnesium supplement daily. At the beginning of the study, people with IBD disease will be included in the study based on the doctor's definitive diagnosis and based on the mentioned entry criteria and answers to the mentioned questionnaires and filling the informed consent form.
Participants/Inclusion and exclusion criteria
The age of patients should be between 18-65 years
Patients with inflammatory bowel disease.
Body mass index in the normal range (18-24.9)
Not suffering from other chronic inflammatory and autoimmune diseases
Absence of pregnancy or breastfeeding, being an athlete or being hospitalized
Lack of severe mental and behavioral disorders
Not using nicotine and its derivatives in the last 6 months
No chronic use of antibiotics, corticosteroids, and immunosuppressants
؛exclusion criteria:
Suffering from other inflammatory diseases
Use of thiopurines
Taking contraceptives and antidepressants
Intervention groups
in the intervention group, one tablet of Neurobion and one tablet of magnesium will be taken daily, and in the placebo group, two placebo tablets will be taken daily for 28 days.
Main outcome variables
Disease activity؛quality of life ؛ chronic fatigue؛muscle strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090822002365N28
Registration date:2023-04-29, 1402/02/09
Registration timing:registered_while_recruiting
Last update:2023-04-29, 1402/02/09
Update count:0
Registration date
2023-04-29, 1402/02/09
Registrant information
Name
Mohammad Reza Vafa
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4734
Email address
vafa.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin B1,B6,B12 and magnesium in disease activity, quality of life and chronic fatigue of inflammatory bowel disease
Public title
Vitamins and Mg in IBD
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
IBD patients in remission
Absence of anemia
Body mass index in the normal range (18-24.9)
- Not suffering from other chronic inflammatory and autoimmune diseases
Absence of pregnancy or breastfeeding, and not being an athlete or being hospitalized
- Absence of severe mental and behavioral disorders
Not using nicotine and its derivatives in the last 6 months
No chronic use of antibiotics, corticosteroids and immunosuppressants
Not taking vitamin and mineral supplements in the last month
Monthly consumption of one vitamin D pearl of 50,000 units
Exclusion criteria:
Suffering from reflux and stomach ulcer and receiving antacid drugs.
Suffering from other inflammatory diseases
Use of thiopurines
Taking contraceptives and antidepressants
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
the participants in this study are divided into placebo and supplement groups based on random codes after completing the consent form. The way of assigning a random number to placebo or supplement is based on milk or line, then the numbers are also printed on the pill boxes during the presence of the patients. In the doctor's office, an envelope containing a number of random numbers is removed, and the number inside the envelope is the patient's number and the number of the can he received.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients participating in the project and the researcher are unaware that each of the patients will receive a placebo or a supplement. And by a third party, is asked to do the randomization.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2023-02-15, 1401/11/26
Ethics committee reference number
IR.IUMS.REC.1401.951
Health conditions studied
1
Description of health condition studied
Inflammatory Bowel Disease
ICD-10 code
K50
ICD-10 code description
Crohn's disease [regional enteritis]
2
Description of health condition studied
Inflammatory Bowel Disease
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis
Primary outcomes
1
Description
Chronic fatigue: It is a complex disorder that lasts for more than a month and cannot be explained by a secondary disease.
Timepoint
The results are evaluated at the beginning of the study and at the end of the 28th day.
Method of measurement
The fatigue questionnaire in IBD patients called IBD-F will be used to measure the severity and impact of fatigue on the patients' activities. Fatigue is measured in each question by scoring on a Likert scale from 0 to 4 . This questionnaire has 3 parts, which will be used in this study from parts 1 and 2.In the first part, the severity of the disease and in the second part, the impact of fatigue in these patients is examined. In the first part, the total score is between 0 and 20. If it is 0, it means no fatigue and no need to answer other parts. The second part includes a score between 0 and 120 (questions 3,4,9,12,13,14 can be answered not be given). The way to calculate the score of the second part is to divide the total score by 120, except for the mentioned questions, multiply by 4 and multiply by 120 in total. The first part has 5 questions and the second part has 30 questions.
2
Description
Quality of life: Quality of life is defined as a person's level of satisfaction with health, relaxation and participation in activities.
Timepoint
The results are evaluated at the beginning of the study and at the end of the 28th day.
Method of measurement
Short form of quality of life questionnaire for patients with inflammatory bowel disease (IBDQ-9) In this validated questionnaire, digestive, systemic, emotional and social complications of inflammatory bowel disease are evaluated. (This questionnaire contains 9 questions related to the effects of inflammatory bowel disease on a person's quality of life, each item is assigned from 1 to 7 points. The validity and reliability of the questionnaire in the Iranian population has also been investigated and confirmed.
3
Description
Disease activity is defined as reversible characteristics of the disease.
Timepoint
The results are evaluated at the beginning of the study and at the end of the 28th day.
Method of measurement
SCCAI-P Questionnaire: In this validated questionnaire, the symptoms, severity and activity of ulcerative colitis are evaluated. There are questions related to the number of bowel movements during the day and night, presence of blood in stool, general health status, Urgent bowel movements and non-gastrointestinal symptoms during the last week are included in this questionnaire.The points assigned to the answers are added up and evaluated based on the final score of disease activity. The range of points is from 0 to 19. According to this questionnaire, people with a score higher than 5 have active ulcerative colitis. sCDAI questionnaire: In this validated questionnaire, the symptoms, severity and activity of Crohn's disease are evaluated. In relation to the number of loose or watery stools, abdominal pain, general health status, use of antidiarrheal drugs, non-gastrointestinal manifestations, presence of abdominal mass, hematocrit and body weight are included in this questionnaire. The points assigned to the answers are added up and evaluated based on the final score of disease activity. The range of points is from 0 to 600. A score less than 150 indicates the recovery phase of the disease, 150 to 219 mild disease, 220 to 450 moderate disease and above 450 severe disease.
Secondary outcomes
1
Description
hand grip/ muscle strength
Timepoint
at baseline and at the end of the study
Method of measurement
normalized handgrip
Intervention groups
1
Description
Intervention group: Intervention group: daily receiving one Mg tablet containing 250 mg Mg and a Neurobion tablet containing 100 mg of vitamin B1, 100 mg of vitamin B6 and 250 mg of vitamin B12.
Category
N/A
2
Description
Control group: In the control group, one Neurobion placebo and one magnesium placebo are used daily.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
gastroentrology clinic
Full name of responsible person
Mohammad Reza vafa
Street address
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4734
Email
rezavafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Street address
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4734
Email
rezavafa@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4734
Email
rezavafa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4734
Email
rezavafa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Reza Vafa
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4734
Email
rezavafa@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
If there is a request to use the data of this study in a meta-analysis or systematic review, the primary and secondary results of this study will be provided to the requesters in the form of joint research.
When the data will become available and for how long
Since the publication of the article resulting from this study, it will be possible to make the data available for the next two years. This time will probably be from the end of 2023 to the end of 2025.
To whom data/document is available
Known researchers from prestigious academic research centers.
Under which criteria data/document could be used
If the intellectual rights of the providers of this research are preserved and the proposed research is aimed at the goals of the current study or solving the clinical problem of the target group of this study, there is a possibility of cooperation.
From where data/document is obtainable
Direct contact with the email address or phone number of the responsible author or the administrators of this research project.
What processes are involved for a request to access data/document
After the contact of the researchers, the process of accessing the data and conducting joint research with the requesters will be done for a maximum of one month.