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Vitamin D3 as a Gut-Soothing sidekick for IBD patients?

NCT ID NCT04225819

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding high-dose vitamin D3 to standard anti-TNF therapy can improve symptoms and reduce inflammation in people with active Crohn's disease or ulcerative colitis. About 100 adults starting anti-TNF treatment will receive either vitamin D3 or a placebo for 14 weeks. The goal is to see if vitamin D3 helps control the disease better than anti-TNF therapy alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Established diagnosis of CD, UC, or IBD-unspecified * Initiating anti-TNF therapy for IBD within 2 weeks of baseline/randomization * Other non-anti-TNF IBD medications must remain stable during the treatment period with the exception of tapering of corticosteroids. * Recent (within 6 months) objective evidence of active IBD on colonoscopy along with elevated inflammatory markers (C-reactive protein \>8 mg/L or fecal calprotectin \>150 mcg/g) * Current disease activity defined as a Harvey Bradshaw index \> 4 at baseline (week 0) for CD subjects or Simple Clinical Colitis Activity Index \> 2 at baseline (week 0) for UC subjects. * Fecal Calprotectin level \>150 mcg/g Exclusion Criteria: * Inability to provide informed consent or unwilling or unlikely to comply with the requirements of the study. * Female subjects who are pregnant, lactating, or intending to become pregnant during the study period * Known intolerance or hypersensitivity to oral vitamin D3 supplementation * Plasma 25(OH)D \> 60 ng/mL * Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies) * Serum calcium \>11 mg/dL * History of hyperparathyroidism * History of renal calculi or chronic kidney disease * Initiation of anti-TNF treatment for extra-intestinal symptoms alone * Evidence of untreated infection (e.g. Clostridium difficile) * History of chronic pancreatitis * History of cystic fibrosis * History of gastric bypass * Presence of stoma or J-pouch

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Conditions

The condition(s) this trial relates to.

Crohn disease inflammatory bowel disease ulcerative colitis vitamin D deficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease IBD Inflammatory bowel diseases Ulcerative colitis Vitamin D3 deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.