Actively Recruiting
Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies
Led by Northwestern University · Updated on 2026-03-23
180
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed moderate to severe ulcerative colitis with a modified Mayo score of 5-9 confirmed by clinical, endoscopic, or histopathological evidence
- Currently starting or switching to an FDA-approved advanced therapy for UC (anti-TNF, anti-IL23, or anti-integrin)
- Mayo endoscopic sub-score of 2 or higher
- Mayo rectal bleeding sub-score of 1 or higher
- Mayo stool frequency sub-score of 2 or higher
- Age between 18 and 85 years
- Able to fully participate in all aspects of the trial
You will not qualify if you...
- Younger than 18 years old
- Currently pregnant, breastfeeding, or planning pregnancy during the study period
- Women of childbearing potential not using highly effective birth control or not postmenopausal for at least 2 years
- Male participants of reproductive potential not using recommended contraception if partner is of reproductive potential
- Medical conditions increasing toxicity risk including type 2 diabetes, hypothyroidism, kidney disease or transplant, infertility
- Abnormal baseline renal, thyroid, or liver function lab results
- Currently taking blood thinners, cholesterol-lowering drugs, antioxidants, warfarin, or medications that interact with selenium
- Allergies to selenium or placebo components
- Known or suspected diagnosis of other colitis types or infectious colitis
- Impending need for hospitalization or urgent colectomy
- Unable or unwilling to comply with supplementation, diet adjustments, or study visits/biospecimen collection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
L
Libeth Rosas, MPH
CONTACT
D
Diego Jimenez Lara
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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