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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090822002365N28
Enrollment
98
Registered
2023-04-29
Start date
2023-04-04
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Inflammatory Bowel Disease. Condition 2: Inflammatory Bowel Disease. Crohn's disease [regional enteritis] Ulcerative colitis

Interventions

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 vi

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion 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

Exclusion criteria: Suffering from reflux and stomach ulcer and receiving antacid drugs. Suffering from other inflammatory diseases Use of thiopurines Taking contraceptives and antidepressants

Design outcomes

Primary

MeasureTime frame
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. Timepoi

Secondary

MeasureTime frame
Hand grip/ muscle strength. Timepoint: at baseline and at the end of the study. Method of measurement: normalized handgrip.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Vafa

Iran University of Medical Sciences

rezavafa@yahoo.com+98 21 8670 4734

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026