Ulcerative Colitis (UC)Phase 2Selenium-UCNCT07427017
Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies
A Phase 2 study testing Selenium supplementation in people with Ulcerative Colitis (UC), run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- What is being tested?
- Selenium supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 therapy
- 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 - vedolizumab
- Mayo endoscopic sub-score ≥2 (moderate to severe)
- Mayo rectal bleeding sub-score ≥1 (moderate to severe)
- Mayo stool frequency sub-score ≥2 (moderate to severe)
- Age 18-85 and able to fully participate in all aspects of the trial
Who cannot join
- Pediatric patients defined by being younger than 18 years of age
- 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.
- 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.
- 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.
- 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.
- 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).
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- 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.
- 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).
- 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, vadadustat
- Allergies to components/compounds used to formulate selenium or placebo supplements.
- 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).
- Concern for impending need for hospitalization or urgent colectomy as determined by the treating provider(s) and/or investigator performing screening/evaluation for enrollment.
- Unwillingness or inability to be compliant with selenium supplementation, adjustments in diet if necessary, or complete study-related visits/biospecimen collection.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Parambir S. Dulai, MD, parambir.dulai@northwestern.edu
About this study
Official title: Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies: A Placebo-Controlled, Double-Blind, Randomized Clinical 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.
Read the detailed description
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.
- Conditions
- Ulcerative Colitis (UC)
- Being tested
- Selenium supplementation, Placebo
- Keywords
- selenium supplementation, ulcerative colitis, selenomethionine, colitis
- Medical subject headings
- Colitis, Ulcerative, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium supplementationDrug
Patients enrolled in the study will receive 200 mcg selenomethionine daily
PlaceboDrug
The placebo group will be taking a placebo supplement once daily
| Study group | Role | What they receive |
|---|---|---|
| Selenium supplementation | Active comparator | Participants enrolled in the active intervention group will be taking a single daily dose of 200 mcg selenomethionine for 12 weeks Receives: Drug: Selenium supplementation |
| Placebo | Placebo comparator | Participants enrolled in the placebo group will be taking a placebo supplement once daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Modified Mayo score of 0-2 with a rectal bleeding sub-score of 0 and endoscopic sub-score of 0-1
Measured: Week 12
Secondary outcomes (8)
Endoscopic improvement
Mayo endoscopic sub-score of 0-1
Measured: Week 12
Endoscopic remission
Mayo endoscopic sub-score of 0
Measured: Week 12
Mucosal healing
Mayo endoscopic sub-score of 0-1 and Geboes histology score ≤ 2
Measured: Week 12
Rectal bleeding
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)
Measured: Week 12
Stool frequency
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)
Measured: Week 12
Numeric Urgency Rating
Score ranges from 0-10 ; higher scores are worse
Measured: Week 12
Fecal calprotectin
Continuous measure
Measured: Week 12
Modified Mayo Score
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)
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start29 Apr 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Prospective, Parallel-Arm, Double-Blind, Placebo- Controlled trial of up to 180 participants (2:1 randomization)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Parambir Dulai, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427017
- Sponsor's protocol ID
- STU00224383
- Other IDs
- R01DK144103
- Acronym
- Selenium-UC
- Status last verified
- Mar 2026
- First submitted
- 15 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenium Supplementation in Moderate-Severely Active Ulcerative Colitis Patients Treated With Advanced Therapies: A Placebo-Controlled, Double-Blind, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07427017
- Acronym / sponsor ID
- Selenium-UC / STU00224383
- Conditions
- Ulcerative Colitis (UC)
- Keywords
- selenium supplementation, ulcerative colitis, selenomethionine, colitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Prospective, Parallel-Arm, Double-Blind, Placebo- Controlled trial of up to 180 participants (2:1 randomization)
| Arm | Type | Receives |
|---|---|---|
| Selenium supplementation | Active comparator | Drug: Selenium supplementationParticipants enrolled in the active intervention group will be taking a single daily dose of 200 mcg selenomethionine for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants enrolled in the placebo group will be taking a placebo supplement once daily for 12 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 therapy
- 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 - vedolizumab
- Age 18-85 and able to fully participate in all aspects of the trial
Key exclusion criteria (13 listed)
- Pediatric patients defined by being younger than 18 years of age
- 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.
- 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).
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selenium supplementationPatients enrolled in the study will receive 200 mcg selenomethionine daily | Drug | Selenium supplementation |
| PlaceboThe placebo group will be taking a placebo supplement once daily | Drug | Placebo |
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
8 secondary outcomes
Endoscopic improvement
Time frame: Week 12
Endoscopic remission
Time frame: Week 12
Mucosal healing
Time frame: Week 12
Rectal bleeding
Time frame: Week 12
Stool frequency
Time frame: Week 12
Numeric Urgency Rating
Time frame: Week 12
Fecal calprotectin
Time frame: Week 12
Modified Mayo Score
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selenium supplementation in people with Ulcerative Colitis (UC), run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Libeth Rosas, MPH (312-503-0006, libeth.rosas@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.