Surplus vitamin B12 use does not reduce fatigue in patients with Irritable Bowel Syndrome or inflammatory bowel disease: A randomized double-blind placebo-controlled trial

Abstract

Objective: In non-conventional care, high doses of vitamin B₁₂ supplementation are used for the treatment of fatigue even in case of normal vitamin B₁₂ blood levels. We performed a randomized placebo controlled trial to investigate the effect of surplus oral vitamin B₁₂ supplementation on fatigue in patients with IBS or IBD.

Methods: This randomized double-blind, placebo-controlled trial included 95 out-clinic IBS and IBD patients with deactivating fatigue and normal vitamin B₁₂ blood levels (≥150 pmol/l) aged 18-65 years. Participants were randomly assigned to receive 1000 μg vitamin B₁₂ daily or a placebo supplement for 8 weeks. The primary outcome measure was fatigue (Checklist Individual Strength (CIS)). In addition, measures of quality of life and depression were examined.

Results: No significant difference in scores of the CIS subscale 'subjective fatigue' was observed between the intervention group and the control group with changes in scores of -8.1 ± 9.5 and -8.3 ± 10.6 (95% CI -11.65 to 6.71), respectively. The scores on the CIS subscale 'motivation' improved with a significant change in scores of -2.2 ± 4.6 (95% CI -4.4 to -0.04). No significantly increased scores were observed for depression or quality of life in the intervention group compared to the control group.

Conclusion: This study did not confirm the expected effect of non-conventional surplus vit B₁₂ supplementation on fatigue in IBS or IBD patients. In addition, no positive effect was observed on depression or quality of life. We conclude that surplus treatment with vitamin B₁₂ in IBS and IBD patients suffering from fatigue has no beneficial clinical effect.

Keywords: Fatigue; IBD; IBS; Vitamin B(12) supplementation.