Selenium Supplementation for Ulcerative Colitis

(Selenium-UC Trial)

Overseen By Diego Jimenez Lara

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Must be taking: Biologics, Small molecules

Must not be taking: Blood thinners, Antioxidants

Disqualifiers: Pregnancy, Diabetes, Hypothyroidism, Kidney disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am starting or switching to a new FDA-approved advanced therapy for my condition.

Mayo endoscopic sub-score ≥2 (moderate to severe)

Mayo rectal bleeding sub-score ≥1 (moderate to severe)

Exclusion Criteria

I am younger than 18 years old.

Patients currently pregnant, expecting to participate in getting pregnant during the study period, or currently lactating

Patients with childbearing potential must use highly effective birth control if not surgically sterile or postmenopausal for ≥ 2 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 200 mcg selenomethionine or a placebo daily for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Selenium

How Is the Trial Designed?

Group I: Selenium supplementation Active Control 1 Intervention

Participants enrolled in the active intervention group will be taking a single daily dose of 200 mcg selenomethionine for 12 weeks

Group II: Placebo Placebo Group 1 Intervention

Participants enrolled in the placebo group will be taking a placebo supplement once daily for 12 weeks

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+