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IRCT20090822002365N28 IRCT 2023-04-29 Iran University of Medical Sciences Vitamins and Mg in IBD The effect of vitamin B1,B6,B12 and magnesium in disease activity, quality of life and chronic fatigue of inflammatory bowel disease 2023-04-04 anticipated 98 Complete https://irct.ir/trial/68662 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 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. 3 Condition 1: Inflammatory Bowel Disease. Condition 2: Inflammatory Bowel Disease. Intervention 1: 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. Intervention 2: Control group: In the control group, one Neurobion placebo and one magnesium placebo are used daily. Yes - There is a plan to make this available What will be shared: 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: 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: Known researchers from prestigious academic research centers. Conditions: 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. Where to obtain: Direct contact with the email address or phone number of the responsible author or the administrators of this research project. How to obtain: 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. Comments:
public Mohammad Reza Vafa
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4734 rezavafa@yahoo.com Iran University of Medical Sciences scientific Mohammad Reza Vafa
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 4734 rezavafa@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both Suffering from reflux and stomach ulcer and receiving antacid drugs. Suffering from other inflammatory diseases Use of thiopurines Taking contraceptives and antidepressants K50 K51 Crohn's disease [regional enteritis] Ulcerative colitis N/A N/A 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. Control group: In the control group, one Neurobion placebo and one magnesium placebo are used daily. 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. 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. 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. Hand grip/ muscle strength. Timepoint: at baseline and at the end of the study. Method of measurement: normalized handgrip. Iran University of Medical Sciences Approved 2023-02-15 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemat Highway, next to Milad Tower, Tehran tehran Tehran Iran (Islamic Republic of)