Abstract

Abstract Background Patients with inflammatory bowel disease(IBD) very often report feeling tired for no reason. Malnutrition and vitamin or mineral deficiencies are also very common among patients with IBD. The aim of this study was to evaluate the efficacy of a multivitamin and mineral supplement for the treatment of fatigue in patients with IBD. Methods Single-centre, randomized placebo-controlled clinical trial to compare a comprehensive over-the-counter multivitamin and mineral supplement (supplemented group) with an identical presented placebo (placebo group) for the treatment of fatigue. Non-vitamin deficient patients with IBD in remission with immunomodulators and/or biological therapy were asked to report score their fatigue on a Visual Analog Scale (0-10) and the validated Chalder fatigue questionnaire (CFQ) at baseline, week 12 and 24. The validated CFQ has a scoring range from 0-33 and 2 subscales physical and psychological fatigue. Patients were considered to be fatigued by the CFQ with a score of 12 or above. Results A total of 214 patients reported fatigue at the start of the study. Of these patients 115 and 99 were assigned to the supplement and placebo groups, respectively. In the supplemented and placebo group, 32 (34%) and 18 (21%) patients, respectively, experienced no fatigue according to the CFQ definition at 24 weeks (Unadjusted Odds Ratio (OR): 2.0 (95% Confidence Interval (CI):1 - 3.8). In particular patients with Ulcerative Colitis (UC) and supplement use experienced less fatigue at 24 weeks (OR 5.7 (95% CI:1.3 - 24.1). Improvement of fatigue experienced between baseline and 24 weeks was not statistical different for either the supplemented and placebo group. Conclusion Although improvement in fatigue score was limited, a significant number of patients with IBD in remission with immunomodulators, and/or biological therapy using a very comprehensive vitamin and mineral supplement reported improvement of fatigue after 24 weeks of use.

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