IBDACTIVATEDNCT04225819
Adjunctive Treatment With Vitamin D3 in Patients With Active IBD
A study testing Vitamin D3 in people with IBD and Inflammatory Bowel Diseases, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Inflammatory bowel disease ((IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC)), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD, Inflammatory Bowel Diseases, Crohn Disease
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial
Inflammatory bowel disease ((IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC)), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The incidence of IBD is increasing worldwide and poses as a burden that reduces quality of life and has a significant impact on health care resources.
The advent of monoclonal antibodies to tumor necrosis factor-α (anti-TNF) has revolutionized treatment of IBD, improving rates of remission and reducing hospitalizations and surgeries. Nevertheless, many patients do not adequately respond to these therapies or lose response over time. Thus, there is an important need for novel immunomodulating agents to improve our ability to achieve remission.
Read more
Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy.
This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.
- Conditions
- IBD, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Vitamin D3 Deficiency
- Being tested
- Vitamin D3, Placebo
- Keywords
- Vitamin D3, Cholecalciferol, IBD, Inflammatory Bowel Disease, Adjunctive treatment, Crohn's Disease, Ulcerative Colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called cholecalciferol
Softgel capsules containing 5,000 IU cholecalciferol (Vitamin D3), sunflower oil, beef gelatin, glycerin, water
PlaceboOther
Sfotgel capsules containing sunflower oil, beef gelatin, glycerin, water
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 supplement | Experimental | Two- 5,000 IU capsules, taken daily with a meal Receives: Dietary Supplement: Vitamin D3 |
| Placebo | Placebo comparator | Two placebo capsules, taken daily with a meal Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome
Patients will complete the SIBDQ questionnaire to measure disease activity at baseline, week 6 and week 14.
Measured: 14 weeks
stool microbiome in IBD patients
Stool samples will be taken at baseline and week 14 to assess change in stool microbiome
Measured: 14 weeks
serum cathelicidin levels
Serum samples will be taken at baseline and week 14 to measure serum cathelicidin levels
Measured: 14 weeks
HBI
Patients with Crohn's Disease will complete the Harvey Bradshaw Index questionnaire to measure disease activity at baseline, week 6 and week 14
Measured: 14 weeks
SCCAI
Patients with Ulcerative Colitis will complete the Simple Clinical Colitis Activity Index questionnaire to measure disease activity at baseline, week 6 and week 14
Measured: 14 weeks
Secondary outcomes (2)
fecal calprotectin
Stool samples will be taken at baseline and week 14 to assess change in fecal calprotectin levels
Measured: 14 weeks
plasma 25(OH)D levels.
Plasma samples will be taken at baseline and week 14 to measure 25(OH)D levels
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Oct 2020
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Why it stopped: Protocol is being modified.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashwin Ananthakrishnan, Massachusetts General Hospital
- Investigators
- Ashwin Ananthakrishnan, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225819
- Sponsor's protocol ID
- 2019P003843
- Acronym
- ACTIVATED
- Status last verified
- Apr 2026
- First submitted
- 3 Jan 2020
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED): A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04225819
- Acronym / sponsor ID
- ACTIVATED / 2019P003843
- Conditions
- IBD, Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Vitamin D3 Deficiency
- Keywords
- Vitamin D3, Cholecalciferol, IBD, Inflammatory Bowel Disease, Adjunctive treatment, Crohn's Disease, Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Protocol is being modified.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 13 Jan 2020 (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.
Inflammatory bowel disease ((IBD), which includes Crohn's disease (CD) and ulcerative colitis (UC)), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The incidence of IBD is increasing worldwide and poses as a burden that reduces quality of life and has a significant impact on health care resources.
The advent of monoclonal antibodies to tumor necrosis factor-α (anti-TNF) has revolutionized treatment of IBD, improving rates of remission and reducing hospitalizations and surgeries. Nevertheless, many patients do not adequately respond to these therapies or lose response over time. Thus, there is an important need for novel immunomodulating agents to improve our ability to achieve remission.
Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy.
This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 supplement | Experimental | Dietary Supplement: Vitamin D3Two- 5,000 IU capsules, taken daily with a meal |
| Placebo | Placebo comparator | Other: PlaceboTwo placebo capsules, taken daily with a meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
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 |
|---|---|---|
| Vitamin D3Also: cholecalciferolSoftgel capsules containing 5,000 IU cholecalciferol (Vitamin D3), sunflower oil, beef gelatin, glycerin, water | Dietary supplement | Vitamin D3 supplement |
| PlaceboSfotgel capsules containing sunflower oil, beef gelatin, glycerin, water | Other | Placebo |
Primary outcome
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome
Time frame: 14 weeks
Patients will complete the SIBDQ questionnaire to measure disease activity at baseline, week 6 and week 14.
stool microbiome in IBD patients
Time frame: 14 weeks
Stool samples will be taken at baseline and week 14 to assess change in stool microbiome
serum cathelicidin levels
Time frame: 14 weeks
Serum samples will be taken at baseline and week 14 to measure serum cathelicidin levels
HBI
Time frame: 14 weeks
Patients with Crohn's Disease will complete the Harvey Bradshaw Index questionnaire to measure disease activity at baseline, week 6 and week 14
SCCAI
Time frame: 14 weeks
Patients with Ulcerative Colitis will complete the Simple Clinical Colitis Activity Index questionnaire to measure disease activity at baseline, week 6 and week 14
2 secondary outcomes
fecal calprotectin
Time frame: 14 weeks
plasma 25(OH)D levels.
Time frame: 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ashwin Ananthakrishnan, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with IBD and Inflammatory Bowel Diseases, run by Massachusetts General Hospital 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 14 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: paused, as of the sponsor's last update on 27 Apr 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Inflammatory Bowel Disease Questionnaire (SIBDQ) outcome (time frame: 14 weeks). The study lists 5 primary outcomes in all. 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 27 Apr 2026.