Inflammatory bowel disease ((IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC)), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The incidence of IBD is increasing worldwide and poses as a burden that reduces quality of life and has a significant impact on health care resources. The advent of monoclonal antibodies to tumor necrosis factor-α (anti-TNF) has revolutionized treatment of IBD, improving rates of remission and reducing hospitalizations and surgeries. Nevertheless, many patients do not adequately respond to these therapies or lose response over time. Thus, there is an important need for novel immunomodulating agents to improve our ability to achieve remission. Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy. This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Softgel capsules containing 5,000 IU cholecalciferol (Vitamin D3), sunflower oil, beef gelatin, glycerin, water
Sfotgel capsules containing sunflower oil, beef gelatin, glycerin, water
Massachusetts General Hospital
Boston, Massachusetts, United States
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome
Patients will complete the SIBDQ questionnaire to measure disease activity at baseline, week 6 and week 14.
Time frame: 14 weeks
stool microbiome in IBD patients
Stool samples will be taken at baseline and week 14 to assess change in stool microbiome
Time frame: 14 weeks
serum cathelicidin levels
Serum samples will be taken at baseline and week 14 to measure serum cathelicidin levels
Time frame: 14 weeks
HBI
Patients with Crohn's Disease will complete the Harvey Bradshaw Index questionnaire to measure disease activity at baseline, week 6 and week 14
Time frame: 14 weeks
SCCAI
Patients with Ulcerative Colitis will complete the Simple Clinical Colitis Activity Index questionnaire to measure disease activity at baseline, week 6 and week 14
Time frame: 14 weeks
fecal calprotectin
Stool samples will be taken at baseline and week 14 to assess change in fecal calprotectin levels
Time frame: 14 weeks
plasma 25(OH)D levels.
Plasma samples will be taken at baseline and week 14 to measure 25(OH)D levels
Time frame: 14 weeks
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