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

Trial Summary

What is the purpose of this trial?

The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.

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.

What data supports the effectiveness of the treatment High-Dose Vitamin D for Inflammatory Bowel Disease?

Research shows that high levels of vitamin D are linked to reduced disease activity in inflammatory bowel disease (IBD) patients, and targeted vitamin D supplementation can help achieve these beneficial levels. Additionally, vitamin D may enhance the effectiveness of other treatments like infliximab, a common IBD medication. ^{1 2 3 4 5}

Is high-dose vitamin D safe for humans?

Research shows that high-dose vitamin D is generally safe for people with inflammatory bowel disease, as studies have evaluated its safety and tolerability in these patients. ^{1 5 6 7 8}

How is high-dose vitamin D different from other treatments for inflammatory bowel disease?

High-dose vitamin D is unique because it focuses on correcting vitamin D deficiency, which is common in inflammatory bowel disease (IBD) patients, and may enhance the effectiveness of biologic therapies like infliximab. Unlike standard treatments that directly target inflammation, this approach aims to support the immune system by maintaining optimal vitamin D levels. ^{1 3 5 6 8}

Research Team

Rebecca Gordon, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of High-dose Cholecalciferol in Patients With Inflammatory Bowel Disease Receiving Infliximab. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Vitamin D in inflammatory bowel disease: more than just a supplement. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Pretreatment 25-hydroxyvitamin D levels and durability of anti-tumor necrosis factor-α therapy in inflammatory bowel diseases. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of a 12-week targeted vitamin D supplementation regimen in patients with active inflammatory bowel disease. [2022]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Iran pubmed.ncbi.nlm.nih.gov

Effect of vitamin D3 supplementation on TNF-α serum level and disease activity index in Iranian IBD patients. [2022]