Ulcerative Colitis (UC)
Selenium or Placebo With Advanced Therapy for Active Ulcerative Colitis
This study is testing whether daily selenium supplementation, compared with placebo, changes response to advanced therapy in adults with moderate-to-severely active ulcerative colitis.
Registry title: Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies
1 recruiting U.S. site ↓Study at a glance
- Age
- 18 Years–85 Years
- Treatment
- Selenium supplementation or Placebo
- Design
- Randomized · Triple
- Central study contact
- Libeth Rosas, MPH312-503-0006libeth.rosas@northwestern.edu
- Sponsor
- Northwestern University
Research question
Does adding daily selenium supplementation improve response to an advanced therapy compared with adding placebo in people with moderate-to-severely active ulcerative colitis?
Participant snapshot
Who the study is looking for
- The study is looking for adults ages 18 through 85 with known or newly diagnosed ulcerative colitis.
- The study is looking for people whose ulcerative colitis is moderate to severe by the specified clinical and endoscopic measures.
- Participants must be starting an approved advanced therapy or switching to a different approved advanced therapy.
- The listed recruiting site is Northwestern University in Chicago, Illinois.
Participation overview
What participation may involve
Participants take either 200 micrograms of selenomethionine or placebo once daily for 12 weeks, beginning within one week of their first dose of a newly started advanced ulcerative colitis therapy. What participation may involve: - Take the assigned selenium or placebo supplement once each day for 12 weeks. - Begin the assigned supplement within one week after the first dose of the advanced therapy. - Complete study visits and biospecimen collection required by the protocol. - Undergo assessments of symptoms, endoscopic findings, inflammation markers, selenium levels, and adverse events through week 12. The active supplementation period lasts 12 weeks; the record also mentions an observational follow-up period but does not report its length.
Study interventions
What participants may receive or do
- Selenium supplementation: Participants assigned to this group take 200 micrograms of selenomethionine by mouth once daily for 12 weeks.
- Placebo: Participants assigned to this group take a placebo supplement once daily for 12 weeks.
Study design
How the comparison works
This Phase 2 study plans to assign up to 180 participants in parallel to daily selenium or placebo while they begin an advanced ulcerative colitis therapy. Assignment is randomized in a 2:1 ratio, with twice as many participants planned for the selenium group as for the placebo group. Participants, investigators, and outcome assessors are masked to treatment assignment. The selenium group is compared with a parallel placebo group. The planned 2:1 assignment means approximately one-third of participants would receive placebo, although an individual's assignment cannot be predicted.
Reported activities
Procedures and tests
- Daily use of the assigned selenium or placebo supplement.
- Assessment of clinical remission using the modified Mayo score, including rectal bleeding and endoscopic subscores.
- Endoscopic assessment for improvement and remission at week 12.
- Histology assessment using the Geboes score as part of the mucosal-healing outcome.
- Assessments of rectal bleeding, stool frequency, and bowel urgency.
- Fecal calprotectin measurement at week 12.
- Monitoring for adverse events and possible selenium toxicity, including blood selenium levels when assessing suspected toxicity.
- Baseline renal, thyroid, and liver laboratory results must meet the protocol's specified ranges.
- Study-related biospecimen collection is required, although the types and schedule are not specified.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must have known or newly diagnosed moderate-to-severe ulcerative colitis, defined by a modified Mayo score of 5 to 9 and supported by clinical, endoscopic, and/or histopathological evidence obtained before screening as standard care.
- Participants must be starting an approved advanced therapy or switching to a different approved advanced therapy.
- The acceptable advanced-therapy classes listed are anti-tumor necrosis factor, anti-interleukin-23, and anti-integrin therapies; the examples also include ustekinumab, described in the record as anti-IL12/23.
- Disease-activity requirements include a Mayo endoscopic subscore of at least 2, rectal-bleeding subscore of at least 1, and stool-frequency subscore of at least 2.
- Participants must be ages 18 through 85 and able to participate fully in all aspects of the trial.
Possible reasons someone may not be able to join
- People who are pregnant, lactating, or expect to participate in becoming pregnant during the study are excluded.
- The record specifies contraception requirements during the 12-week active intervention period for participants of reproductive potential and certain partners.
- Medical conditions identified as increasing toxicity risk include type 2 diabetes, hypothyroidism, acute or chronic kidney disease, kidney transplant history, and infertility history.
- Baseline kidney, thyroid, or liver laboratory results outside the protocol's specified ranges are exclusionary.
- People taking listed blood thinners, cholesterol-lowering drugs, antioxidants, warfarin, immune-dependent medications, or other specified medicines that may interact with selenium are excluded.
- An allergy to ingredients used in the selenium or placebo supplements is exclusionary.
- People with known or suspected Crohn's colitis, indeterminate, ischemic, radiation, microscopic, or infectious colitis, or diverticular disease associated with colitis, are excluded.
- People whose treating provider or investigator is concerned that hospitalization or urgent colectomy may soon be needed are excluded.
- Participants must be willing and able to follow supplementation and any necessary dietary adjustments and complete study visits and biospecimen collection.
Important unknowns
What the record does not make clear
- The record does not state how many study visits are required, when they occur, or how long they last.
- The active intervention lasts 12 weeks, but the record mentions an observational follow-up period without stating its duration.
- Participants begin or switch advanced therapy, but the record does not fully explain which other ulcerative colitis medicines may continue or change.
- The record lists prohibited medicines but does not report whether any require a washout period before enrollment.
- The record does not describe rescue treatment or what happens if ulcerative colitis worsens during the study.
- Week-12 outcomes use endoscopic and histology scores, but the record does not specify the exact endoscopy schedule, preparation, sedation, or whether prior standard-care results can be used.
- The record does not identify which study-related or standard-care costs are covered or billed to insurance.
- The record does not state whether participants receive compensation.
- The record does not state whether parking, transportation, lodging, or other travel expenses are reimbursed.
- The record lists one Chicago site but does not say whether any visits or assessments can be completed remotely or locally.
- The record does not describe whether selenium supplementation is provided after the active intervention ends.
Before contacting the site
Questions for the study team
- What is the complete visit schedule, including screening, week-12 assessments, and observational follow-up?
- Which advanced therapies are currently accepted, and does the listed example for each drug match the protocol's permitted class?
- Which current medicines, vitamins, antioxidants, or supplements must be stopped, and is a washout period required?
- What endoscopies, biopsies, blood tests, stool tests, and other biospecimens are required, and which are research-only?
- What happens if ulcerative colitis symptoms worsen or urgent treatment is needed during the study?
- Which study-related costs are covered, what may be billed to insurance, and is compensation or travel reimbursement available?
- Can any visits, laboratory tests, or follow-up activities be completed remotely or outside the Chicago site?
- How are possible selenium toxicity and other adverse events monitored, and what findings would cause supplementation to stop?
Before changing care
Questions for your gastroenterologist
- How stable is my ulcerative colitis, and are there signs that I may need hospitalization, surgery, or a faster treatment change?
- Which approved advanced therapies are reasonable alternatives for me, and how would the study affect the timing of starting or switching treatment?
- Could any of my current medicines or supplements interact with selenium, and should any changes be coordinated with the research team?
- How would study-related endoscopy, laboratory testing, and biospecimen collection fit with my standard ulcerative colitis care?
- What plan should my gastroenterology and research teams follow if my symptoms worsen or my advanced therapy needs adjustment?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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 design and administration
- Organization
- Northwestern University
- Organization class
- Other
- Organization study ID
- STU00224383
- Lead sponsor
- Northwestern University
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- Triple
- Who is masked
- Participant, Investigator, Outcomes Assessor
- Standard age groups
- Adult, Older Adult
Study 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
Interventions: Drug: Selenium supplementation
Placebo Comparator
Placebo
Participants enrolled in the placebo group will be taking a placebo supplement once daily for 12 weeks
Interventions: Drug: Placebo
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
Eligibility
18 Years–85 Years
All
Not accepted
Inclusion criteria (6)
- Known or newly diagnosed moderate to severe UC (as defined by the modified Mayo score of 5-9; confirmed by clinical, endoscopic, and/or histopathological evidence prior to screening as per standard of care) who are either being started on or are being switched to a different FDA approved advanced therapyRegistry-derived · unreviewed
- The acceptable list of advanced therapies is (anti-TNF, anti-IL23, anti-integrin). For example, anti-tumor necrosis factor - infliximab, adalimumab, golimumab, certolizumab; anti-IL12/23 - ustekinumab, mirikizumab, risakizumab, guselkumab; anti-integrin - vedolizumabRegistry-derived · unreviewed
- Mayo endoscopic sub-score ≥2 (moderate to severe)Registry-derived · unreviewed
- Mayo rectal bleeding sub-score ≥1 (moderate to severe)Registry-derived · unreviewed
- Mayo stool frequency sub-score ≥2 (moderate to severe)Registry-derived · unreviewed
- Age 18-85 and able to fully participate in all aspects of the trialRegistry-derived · unreviewed
Exclusion criteria (13)
- Pediatric patients defined by being younger than 18 years of ageRegistry-derived · unreviewed
- Patients who are currently pregnant, expecting to participate in getting pregnant during the study period through natural or assisted techniques (in-vitro fertilization, intra-uterine insemination, intracytoplasmic sperm injection, embryo transfer, planned egg or sperm donor), or are currently lactating.Registry-derived · unreviewed
- Women with childbearing potential will be required to use highly effective birth control if not surgically sterile or postmenopausal for ≥ 2 years for the duration of the active intervention period. Highly effective forms of birth control include those that alone or in combination result in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly. This would include combined pill and progestin-only pill, evra patch, nuvaring, depo-provera, paragard, mirena, implanon, female sterilization, male sterilization.Registry-derived · unreviewed
- The criteria for being considered postmenopausal would be the following: twelve months of spontaneous amenorrhea or; six months of spontaneous amenorrhea with serum FSH levels 40 mIU/mL or; six weeks post-surgical bilateral oophorectomy with or without hysterectomy.Registry-derived · unreviewed
- Male subjects are considered of reproductive potential unless surgically sterile (e.g., vasectomy) and should not participate in activities of reproductive potential other than heterosexual intercourse (e.g., they should not participate in in-vitro fertilization or other reproductive assistance techniques) during the active intervention period of 12 weeks. Male subjects of reproductive potential that have female partners of reproductive potential should commit to the use of recommended contraception in the partnership during the active intervention period of 12 weeks, and be informed of the recommendations for pregnancy screening during the intervention phase of the trial. Additionally, male subjects (regardless of reproductive potential) that have partners that are currently pregnant should commit to condom use during intercourse to prevent transmission of the drug product through semen during the active intervention period of 12 weeks.Registry-derived · unreviewed
- If participants become pregnant during the intervention period, they will be withdrawn to avoid risks to the fetus. If participants become pregnant during the follow-up observational period, they will be permitted to remain in the study as no active intervention is being administered. Research related assessments and visits will be tailored to those recommended during pregnancy by the treating provider(s).Registry-derived · unreviewed
- Medical conditions that may predispose to toxicity including a history of type 2 diabetes mellitus, hypothyroidism, acute or chronic kidney disease, history of kidney transplant, history of infertility.Registry-derived · unreviewed
- Abnormal baseline labs for renal function, thyroid function, or hepatic function: Renal function panel including creatinine (results should fall within normal lab reference ranges below 1.3 mg/dL for males and 1.1 mg/dL for females). Thyroid function tests with thyroid stimulating hormone (TSH; results should fall within normal lab reference ranges of 0.5 to 5.0 mIU/L). Hepatic function panel (results should fall within normal lab reference ranges) including alanine aminotransaminase (below 55 U/L for males and 45 U/L for females), aspartate aminotransferase (below 40 U/L for males and 32 U/L for females), total bilirubin (below 1.2 mg/dL), direct bilirubin (below 0.3 mg/dL), alkaline phosphatase (below 120 IU/L for males and 104 IU/L for females).Registry-derived · unreviewed
- Any patient taking blood thinners, cholesterol-lowering drugs, antioxidants, warfarin, or any other immune system-dependent medications that may interact with selenium. Specifically, they should not be taking any of the following: alendronate, baloxavir marboxil, cinoxacin, ciprofloxacin, deferiprone, delafloxacin, dimercaprol, eltrombopag, enoxacin, etidronate, gatifloxacinm gemifloxacin, grepafloxacin, ibandronate, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, patiromer, penicillamine, risedronate. sodium polystyrene sulfonate, sparfloxacin. tiludronate, trientine, trovafloxacin, vadadustatRegistry-derived · unreviewed
- Allergies to components/compounds used to formulate selenium or placebo supplements.Registry-derived · unreviewed
- Known or suspected diagnosis of Crohn's colitis, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or infectious colitis (Clostridium difficile, cytomegalovirus (CMV), any other pathogenic illness felt by the investigator to be the source of colitis).Registry-derived · unreviewed
- Concern for impending need for hospitalization or urgent colectomy as determined by the treating provider(s) and/or investigator performing screening/evaluation for enrollment.Registry-derived · unreviewed
- Unwillingness or inability to be compliant with selenium supplementation, adjustments in diet if necessary, or complete study-related visits/biospecimen collection.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Clinical Remission
Time frame: Week 12
Modified Mayo score of 0-2 with a rectal bleeding sub-score of 0 and endoscopic sub-score of 0-1
Secondary outcome
Endoscopic improvement
Time frame: Week 12
Mayo endoscopic sub-score of 0-1
Secondary outcome
Endoscopic remission
Time frame: Week 12
Mayo endoscopic sub-score of 0
Secondary outcome
Mucosal healing
Time frame: Week 12
Mayo endoscopic sub-score of 0-1 and Geboes histology score ≤ 2
Secondary outcome
Rectal bleeding
Time frame: Week 12
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)
Secondary outcome
Stool frequency
Time frame: Week 12
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)
Secondary outcome
Numeric Urgency Rating
Time frame: Week 12
Score ranges from 0-10 ; higher scores are worse
Secondary outcome
Fecal calprotectin
Time frame: Week 12
Continuous measure
Secondary outcome
Modified Mayo Score
Time frame: Week 12
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)
Recruiting locations in the United States
Northwestern University
RecruitingChicago, Illinois, 60611, United States
Parambir S. Dulai, MDparambir.dulai@northwestern.edu
Central study contacts
Registry dates
- First posted
- Feb 23, 2026
- Primary completion
- Dec 2028
- Overall completion
- Dec 2028
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.