High-Dose Vitamin D for Inflammatory Bowel Disease

Overseen By Rebecca Gordon, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Must be taking: Biologics

Must not be taking: Anti-epileptics, Lasix

Disqualifiers: Kidney disease, Liver disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 64 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether high-dose vitamin D can benefit individuals with Inflammatory Bowel Disease (IBD) who are already receiving biologic therapy, a treatment using living organisms or substances derived from them. The researchers aim to determine if adding vitamin D to their regimen can enhance their condition during regular medication infusions. Participants will undergo additional blood tests and complete questionnaires. Individuals with IBD, such as Crohn's or ulcerative colitis, who receive regular treatment infusions and have low vitamin D levels may be suitable for this study.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking or have taken anti-epileptic medication or Lasix in the past 3 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that high doses of vitamin D are generally safe for people with inflammatory bowel disease (IBD). One study found that vitamin D supplements reduced IBD-related emergency room visits by 2.17%, indicating fewer people needed urgent care. Another study examined high-dose vitamin D in patients taking infliximab, a common IBD treatment, and found that most participants did not experience serious side effects from the vitamin D.

Although these studies do not provide specific details on side effects, the absence of major issues suggests that vitamin D is safe. Joining a clinical trial is a personal choice, and knowing that vitamin D has been well-received in past studies might assist in making that decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for inflammatory bowel disease (IBD) involve medications like biologics that target specific proteins in the immune system to reduce inflammation. However, high-dose vitamin D is unique because it leverages the vitamin's potential anti-inflammatory properties and its role in immune system regulation. Researchers are excited about this approach because vitamin D could complement existing therapies by enhancing their effectiveness or reducing reliance on more aggressive medications. Additionally, vitamin D is a nutrient that is generally well-tolerated, which may lead to fewer side effects compared to traditional medications.

What evidence suggests that high-dose vitamin D might be an effective treatment for inflammatory bowel disease?

This trial will evaluate the effects of high-dose vitamin D supplementation combined with biologic therapy for individuals with inflammatory bowel disease (IBD). Research has shown that vitamin D levels can influence how people with IBD feel. Studies have found that patients with higher vitamin D levels are more likely to experience periods where their symptoms lessen or disappear during biologic therapy. A review of several studies found that vitamin D supplements can significantly increase vitamin D levels in people with IBD, leading to better health outcomes. Many people with IBD have low vitamin D levels, which is linked to worse health. Overall, promising evidence suggests that increasing vitamin D can help improve IBD symptoms when used with other treatments. ^{1 2 6 7 8}

Who Is on the Research Team?

Rebecca Gordon, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for young people aged 5-25 with Inflammatory Bowel Disease (IBD) like Crohn's or ulcerative colitis, who are on biologic therapies Infliximab or Vedolizumab. They must have low vitamin D levels without recent changes in supplements and no kidney, liver diseases, granulomatous disease, high calcium issues, or certain medications.

Inclusion Criteria

My vitamin D level is below 40 ng/mL, and I haven't changed my supplements recently.

I have been diagnosed with inflammatory bowel disease (IBD).

I am on Infliximab or Vedolizumab treatment every 4-8 weeks.

Exclusion Criteria

I have been on anti-epileptic medication or Lasix in the last 3 months.

I have a history of liver disease.

I have a history of kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral high dose interval vitamin D concurrently with biologic therapy every 4-8 weeks

64 weeks

Visits every 4-8 weeks for biologic therapy and additional bloodwork

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Biologic Therapy
• High Dose Interval Vitamin D

Trial Overview The study tests if taking high doses of vitamin D at the same time as biologic treatments for IBD helps patients. It involves extra blood tests and questionnaires during their regular infusion appointments to monitor effects.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

Patients with inflammatory bowel disease (IBD) have significantly lower serum levels of 25-hydroxyvitamin D (250HD) compared to healthy controls, indicating a potential deficiency in vitamin D among these patients.

Despite the lower vitamin D levels, there was no association found between vitamin D intake, serum 250HD, or parathyroid hormone (PTH) levels and bone mineral density (BMD) in IBD patients, suggesting that malabsorption may not be a major cause of bone loss in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationships between vitamin D, parathyroid hormone and bone mineral density in inflammatory bowel disease. Silvennoinen, J.[2022]

Low vitamin D levels in patients with inflammatory bowel diseases (IBD) are linked to higher disease activity, increased risk of surgeries and hospitalizations, and poorer quality of life, based on a large referral IBD cohort study.

The authors emphasize the need for interventional studies to explore whether vitamin D supplementation can effectively reduce disease activity in IBD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: Vitamin D and IBD: Can We Get Over the "Causation" Hump? Ananthakrishnan, AN.[2018]

In a study of 43 pediatric and young adult patients with inflammatory bowel disease (IBD) and vitamin D deficiency, high-dose cholecalciferol supplementation was well-tolerated, but only 37% of participants achieved sufficient vitamin D levels after one year.

Patients receiving 100,000 IU of cholecalciferol every 6 to 8 weeks had a higher mean increase in vitamin D levels compared to those receiving 50,000 IU every 4 to 5 weeks, yet less than half reached the target sufficiency, indicating that higher doses may be necessary for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of High-dose Cholecalciferol in Patients With Inflammatory Bowel Disease Receiving Infliximab. Gordon, RJ., Wells, R., Johansen, C., et al.[2023]

In a study of 101 patients with inflammatory bowel disease (IBD), those with insufficient vitamin D levels (<30 ng/mL) experienced earlier cessation of anti-TNF-α therapy, indicating that vitamin D status may impact the effectiveness of this treatment.

Patients with low vitamin D levels had a significantly higher risk of losing response to anti-TNF-α therapy, particularly in those with Crohn's disease, suggesting that monitoring and potentially supplementing vitamin D could enhance treatment durability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretreatment 25-hydroxyvitamin D levels and durability of anti-tumor necrosis factor-α therapy in inflammatory bowel diseases. Zator, ZA., Cantu, SM., Konijeti, GG., et al.[2018]

In a study of 108 patients with inflammatory bowel disease (IBD), treatment with 50,000 IU of vitamin D3 for 12 weeks significantly increased serum vitamin D levels from 15.54 to 67.89 ng/ml (p=0.00).

While there was a reduction in tumor necrosis factor-alpha (TNF-α) levels after vitamin D3 treatment, this change was not statistically significant (p=0.07), indicating that further research is needed to fully understand the impact of vitamin D3 on inflammation in IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of vitamin D3 supplementation on TNF-α serum level and disease activity index in Iranian IBD patients. Dadaei, T., Safapoor, MH., Asadzadeh Aghdaei, H., et al.[2022]

High-dose vitamin D3 supplementation at 10,000 IU daily significantly increased serum 25-hydroxy-vitamin D levels in patients with Crohn's disease, indicating effective absorption and potential benefits for bone health and immune function.

While the overall relapse rates of Crohn's disease were similar between high-dose and low-dose groups, a per-protocol analysis showed that none of the patients on high-dose vitamin D3 experienced a relapse, suggesting a possible protective effect that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn's Disease in Remission: A Pilot Randomized Double-Blind Controlled Study. Narula, N., Cooray, M., Anglin, R., et al.[2022]

A 12-week vitamin D supplementation regimen successfully increased serum 25(OH)D levels to the target range of 100-125 nmol/L in patients with active inflammatory bowel disease (IBD), with no serious adverse events reported.

While the treatment improved symptom-based activity scores in patients, it did not significantly change objective markers of inflammation, indicating that while vitamin D may help with symptoms, its effects on inflammation need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a 12-week targeted vitamin D supplementation regimen in patients with active inflammatory bowel disease. Garg, M., Rosella, O., Rosella, G., et al.[2022]

Vitamin D plays a protective role in the gastrointestinal tract by regulating gut barrier function and enhancing immune responses, which is crucial for patients with inflammatory bowel disease (IBD).

Vitamin D deficiency is common in IBD patients (30-40%) and is linked to worse disease outcomes, but the effectiveness of vitamin D supplementation in improving clinical outcomes remains uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vitamin D in inflammatory bowel disease: more than just a supplement. Gubatan, J., Moss, AC.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S154235652500624X

The Real-World Impact of Vitamin D Supplementation on ... Vitamin D deficiency is common in inflammatory bowel disease (IBD) and is linked to worse clinical outcomes. However, the impact of vitamin ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12175088/

Evaluating the predictive effect of vitamin D on clinical ... After receiving IFX therapy, CD patients in eastern China with higher VIT-D levels were more likely to achieve clinical remission.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04331639

High Dose Interval Vitamin D Supplementation in Patients ... High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy. ClinicalTrials.gov ID NCT04331639.

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

Association between Inflammatory Bowel Disease and ... Hypovitaminosis D is reported to be as high as 60% in IBD patients, although it is not clear whether it results from IBD-related malabsorption due to intestinal ...

5. 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... According to the results of meta-analysis, the level of 25(OH)D3 in patients with IBD after VitD supplementation was significantly increased, which effect was ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35045559/

Efficacy and Safety of High-dose Cholecalciferol in Patients ... The goal of this study was to assess the efficacy and safety of high-dose, interval cholecalciferol administration in patients with IBD receiving infliximab.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10542962/

Vitamin D for the treatment of inflammatory bowel disease - PMC When comparing high and low doses of vitamin D, there were no data for clinical response, but there may be no difference in relapse for CD. We cannot draw ...

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

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