Vitamin D for Inflammatory Bowel Disease

(PIVD Trial)

Overseen By Samantha C Hess, BSc Honours

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Terry Ponich

Must be taking: Vitamin D

Must not be taking: Oral corticosteroids

Disqualifiers: Rheumatoid arthritis, Thyroid disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of Vitamin D supplements on individuals with Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. The researchers aim to determine if taking 2,000 IU of Vitamin D daily can enhance health and quality of life for IBD patients and assess adherence to the supplement routine over 12 months. The study also examines whether disease severity affects adherence to the supplement plan. Individuals diagnosed with IBD and receiving ongoing care at specific hospitals may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to explore its effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using oral corticosteroids for diseases other than IBD, you cannot participate in the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that taking Vitamin D is generally safe and well-tolerated. Studies have found that Vitamin D can help reduce inflammation and improve gut health in people with inflammatory bowel disease (IBD). Although Vitamin D is usually safe, excessive long-term intake can lead to high calcium levels. However, the trial's dosage of 2000 IU per day is considered safe for most individuals. Previous studies suggest that addressing Vitamin D deficiency is a sensible approach for those with IBD, with minimal risk of side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Vitamin D3 for treating Inflammatory Bowel Disease (IBD) because it takes a different approach compared to standard treatments like anti-inflammatory drugs, immunosuppressants, and biologics. Unlike these medications, which primarily target inflammation or suppress the immune system, Vitamin D3 may modulate the immune response more naturally and improve gut health. Additionally, Vitamin D3 is a simple, well-tolerated supplement that could offer a safer long-term option with fewer side effects. This makes it a promising alternative for those seeking more natural and holistic ways to manage their IBD symptoms.

What evidence suggests that Vitamin D might be an effective treatment for IBD?

Research has shown that Vitamin D can benefit people with Crohn's disease, a type of inflammatory bowel disease (IBD). Studies have found that Vitamin D reduces the chance of symptoms returning in Crohn's patients, though this effect is less clear for those with ulcerative colitis. People with IBD often have low Vitamin D levels, so supplements might be beneficial. Vitamin D may also reduce emergency room visits related to IBD by helping the body stay in remission, resulting in fewer or no symptoms. Overall, Vitamin D supports gut health by reducing inflammation and aiding in the healing of the intestinal lining. Participants in this trial will receive Vitamin D3 and take a 2000 IU pill daily for 12 months to evaluate its effects on IBD. ^{2 4 6 7 8}

Who Is on the Research Team?

Terry Ponich, MD

Principal Investigator

Victoria Hospital - London Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for individuals with Inflammatory Bowel Disease (IBD), including those diagnosed with Ulcerative Colitis or Crohn's Disease, who are vitamin D deficient. Participants will be required to take Vitamin D supplements daily and complete surveys and tests over a year.

Inclusion Criteria

Patients within outpatient gastroenterology clinics at Victoria Hospital and St. Joseph's Hospital with follow-up appointments within the next 2 years (ongoing IBD care)

Participants must have the ability to read, comprehend, and voluntarily provide informed consent without assistance

I am between 18 and 85 years old.

Exclusion Criteria

Those who were seen once by the gastroenterology team but never followed up (no ongoing IBD care)

I do not have conditions like arthritis, thyroid, or bone diseases that affect calcium or Vitamin D levels.

I do not have kidney failure, chronic liver disease, or high calcium levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take 2000 IU of Vitamin D daily for 12 months

12 months

Initial visit, 6-month follow-up, 12-month follow-up

Follow-up

Participants are monitored for adherence and health-related quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vitamin D3 (Cholecalciferol)

Trial Overview

The study is testing the effects of daily Vitamin D3 supplementation on IBD patients' disease activity and quality of life. It examines adherence to taking 2000 IU of Vitamin D every day for 12 months, its impact on health-related quality of life, and maintaining adequate blood levels.

How Is the Trial Designed?

Group I: Vitamin D Experimental Treatment 1 Intervention

Participants who have IBD (UC or CD) will receive Vitamin D3 and will take a 2000 IU pill daily for 12 months.

Who Is Running the Clinical Trial?

Terry Ponich

Lead Sponsor

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S154235652500624X

The Real-World Impact of Vitamin D Supplementation on ...

Vitamin D was associated with lower risk of relapse in patients with Crohn's disease (CD) but not in those with ulcerative colitis (UC). The ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4615394/

Association between Inflammatory Bowel Disease and ...

Meta-analysis showed that patients with IBD had 64% higher odds of vitamin D deficiency when compared to controls (OR = 1.64; 95% CI: 1.30, 2.08; I2 = 7%; p < ...

3.

cghjournal.org

cghjournal.org/article/S1542-3565(25)00624-X/abstract

The Real-World Impact of Vitamin D Supplementation on ...

Vitamin D supplementation was associated with reduction in IBD-related emergency department visits by 2.17% (34.4% relative risk reduction; P = ...

4.

journals.lww.com

journals.lww.com/md-journal/fulltext/2018/11160/efficacy_of_vitamin_d_in_treatment_of_inflammatory.4.aspx

Efficacy of vitamin D in treatment of inflammatory bowel...

Recent studies have found that VitD can induce and maintain IBD remission through antibiosis, anti-inflammatory, and repair of intestinal mucosal barriers, thus ...

5.

frontiersin.org

frontiersin.org/journals/immunology/articles/10.3389/fimmu.2025.1578191/full

Evaluating the predictive effect of vitamin D on clinical ...

It is estimated that 30% of inflammatory bowel disease (IBD) patients experience a loss of response to infliximab (IFX) during the course of ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6566188/

The Role of Vitamin D in Inflammatory Bowel Disease

Vitamin D deficiency has been associated with inflammatory diseases including inflammatory bowel disease (IBD).

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04225819

Adjunctive Treatment With Vitamin D3 in Patients ...

HBI, Patients with Crohn's Disease will complete the Harvey Bradshaw Index questionnaire to measure disease activity at baseline, week 6 and week 14, 14 weeks.

8.

academic.oup.com

academic.oup.com/ecco-jcc/article/6/4/397/425715?login=true

Management of inflammatory bowel disease with vitamin D

Given current evidence and the apparent safety of vitamin D supplementation, it appears reasonable to screen for and treat vitamin D deficiency in patients with ...