MedTrace Logo

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

NCT07427017 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-05-22

No results posted yet for this study

Summary

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

  • Ulcerative Colitis (UC)

Interventions

DRUG

Selenium supplementation

Patients enrolled in the study will receive 200 mcg selenomethionine daily

DRUG

Placebo

The placebo group will be taking a placebo supplement once daily

Sponsors & Collaborators

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

    collaborator NIH

  • Northwestern University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-29
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07427017 on ClinicalTrials.gov