Eficácia e aderência à suplementação de vitamina D em pacientes com doença de Crohn em remissão e Hipovitaminose D: estudo piloto de um ensaio clínico randomizado, duplo-cego, placebo-controlado

Abstract

Crohn's disease (CD) is an immune-mediated inflammatory bowel disease. It is known that vitamin D plays a role in regulating the immune response and helps maintain musculoskeletal integrity. Patients with CD often have low serum vitamin D levels. The present study aims to evaluate the effect of vitamin D supplementation on muscle strength and fatigue in patients with CD and D hypovitaminosis. Secondarily, it will also be observed if the dose of 50,000 IU / weekly of vitamin D is well tolerated and capable of raising serum vitamin D levels (25-OH-D) in the patients studied. This was a pilot study involving 10 patients from a current, double-blind, randomized, placebo-controlled clinical trial, which will comprise a sample of 110 patients with CD in remission. Patients were randomly allocated into two groups: weekly doses of 50,000 IU of vitamin D or placebo for 6 months. Muscle strength was assessed by manual dynamometry and self-reported fatigue using the Chalder questionnaire taken before and at the end of the 6th month after the intervention. Weekly contacts were conducted via telephone to assess adverse effects and tablet counts at 3-month intervals to assess adherence. All patients remained in remission until completion of the study. No adverse effects were reported and adherence to vitamin D supplementation was observed. Vitamin D levels reached values within the lower limits of normality, but the increase in muscle strength in the test group was not observed. In this group, two patients (100%) with fatigue in the inclusion obtained a reversion of fatigue after the intervention. The vitamin D replacement protocol was well tolerated and generated good adherence in the study population. This intervention elevated serum levels of vitamin D, but was unable to generate increased muscle strength, although it produced reduced fatigue symptoms. These preliminary findings suggest a possible benefit of vitamin D for the treatment of fatigue in CD, which should be confirmed with the increase in the casuistry. ClinicalTrials.gov Identifier NCT02704624. Date of registration: 02/24/2016.