Micronutrient deficiencies are common in ulcerative colitis (UC). Selenium deficiency is associated with worse disease outcomes including disease flares and need for surgery. Previous in vitro and in vivo studies demonstrated that selenium regulates colonic inflammation, and that selenium supplementation protects against DSS-induced colitis. In this proof-of-concept clinical trial, we aim to test the hypothesis that selenium supplementation in moderate to severely active UC patients will improve responsiveness to advanced therapy such as biologics and small molecules.
Ulcerative colitis (UC) is an immune-mediated inflammatory condition of the colon characterized by mucosal inflammation and bloody diarrhea. UC affects over 1 million Americans with a rapidly growing international prevalence. The primary driver of disease impact in UC is uncontrolled inflammation and disease flares with downstream effects related to disease complications, including lower quality of life, hospitalizations, surgery, and development of colon cancer. Micronutrients exert a critical influence on immune responses, and micronutrient deficiencies have been linked to immune mediated inflammation. Micronutrient deficiencies are common in UC patients, even during periods of quiescent disease. Deficiency of one micronutrient in particular, selenium, is associated with an increased risk for disease flare and need for surgery in UC. Given selenium is a naturally occurring micronutrient found in many foods and sold over the counter as a dietary supplement or as part of multi-vitamin supplements, demonstration of its efficacy as a supplement in UC would offer an opportunity to better guide the use of these in routine practice through nutritional counseling and optimization of disease outcomes with minimal additive risk. Patients enrolled in the study will either receive 200 mcg selenomethionine daily or a placebo supplement daily depending on their randomization group. Daily selenomethionine or placebo. The supplementation should begin within 1 week of the first dose of the advanced therapy initiation for UC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
180
Patients enrolled in the study will receive 200 mcg selenomethionine daily
The placebo group will be taking a placebo supplement once daily
Northwestern University
Chicago, Illinois, United States
RECRUITINGClinical Remission
Modified Mayo score of 0-2 with a rectal bleeding sub-score of 0 and endoscopic sub-score of 0-1
Time frame: Week 12
Endoscopic improvement
Mayo endoscopic sub-score of 0-1
Time frame: Week 12
Endoscopic remission
Mayo endoscopic sub-score of 0
Time frame: Week 12
Mucosal healing
Mayo endoscopic sub-score of 0-1 and Geboes histology score ≤ 2
Time frame: Week 12
Rectal bleeding
Proportion of participants with any improvement in rectal bleeding score from baseline (any reduction in Mayo rectal bleeding sub-score, the Mayo rectal bleeding sub-score ranges from 0-3; a higher score indicates more blood seen)
Time frame: Week 12
Stool frequency
Proportion of participants with any improvement in stool frequency score from baseline (any reduction in Mayo stool frequency sub-score, Mayo stool frequency sub-score ranges from 0-3; higher score indicates more abnormality in stool frequency)
Time frame: Week 12
Numeric Urgency Rating
Score ranges from 0-10 ; higher scores are worse
Time frame: Week 12
Fecal calprotectin
Continuous measure
Time frame: Week 12
Modified Mayo Score
Sum of Mayo rectal bleeding sub-score, Mayo stool frequency sub-score, and Mayo endoscopic sub-score (score ranges from 0-9, a higher score indicates more severe disease)
Time frame: Week 12
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