Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07427017
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Selenium supplementation — DRUG
    Patients enrolled in the study will receive 200 mcg selenomethionine daily
  • Placebo — DRUG
    The placebo group will be taking a placebo supplement once daily

Study Details

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.

Key Dates

Start date
Apr 29, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Selenium supplementation
    Participants enrolled in the active intervention group will be taking a single daily dose of 200 mcg selenomethionine for 12 weeks
  • Placebo Comparator: Placebo
    Participants enrolled in the placebo group will be taking a placebo supplement once daily for 12 weeks

Primary Outcome Measure

Clinical Remission [ Time Frame: Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Parambir S. Dulai, MD
[email protected]

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By research site
Northwestern University· Chicago, IL

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