High-Dose Vitamin D for Inflammatory Bowel Disease
Recruiting in Palo Alto (17 mi)
Overseen byRebecca Gordon, MD
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
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
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.
12345Is 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.
15678How 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.
13568Eligibility 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.
+1 more
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.
+3 more
Trial 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
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
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Who Is Running the Clinical Trial?
Boston Children's HospitalLead Sponsor
References
Efficacy and Safety of High-dose Cholecalciferol in Patients With Inflammatory Bowel Disease Receiving Infliximab. [2023]Vitamin D deficiency is prevalent in patients with inflammatory bowel disease (IBD). The goal of this study was to assess the efficacy and safety of high-dose, interval cholecalciferol administration in patients with IBD receiving infliximab.
Vitamin D in inflammatory bowel disease: more than just a supplement. [2019]The aim of this review is to explore the protective role of vitamin D on the gastrointestinal tract, summarize the epidemiology of vitamin D deficiency in inflammatory bowel disease (IBD), and highlight recent studies examining the impact of low vitamin D and vitamin D supplementation on IBD clinical outcomes.
Pretreatment 25-hydroxyvitamin D levels and durability of anti-tumor necrosis factor-α therapy in inflammatory bowel diseases. [2018]Emerging evidence supports an immunologic role for 25-hydroxyvitamin D (25(OH)D) in inflammatory bowel disease (IBD). Here we examined if pretreatment vitamin D status influences durability of anti-tumor necrosis factor (TNF)-α therapy in patients with Crohn's disease (CD) or ulcerative colitis (UC).
Editorial: Vitamin D and IBD: Can We Get Over the "Causation" Hump? [2018]Vitamin D deficiency is common in patients with inflammatory bowel diseases and may even precede the disease onset contributing to an increased risk. Using comprehensive data from a large, referral IBD cohort, Kabbani et al. establish that low vitamin D levels are associated with greater disease activity, increased risk of surgery and hospitalizations, and lower health-related quality of life in patients with IBD. This expands the evidence base supporting such an association. However, there is a need for this field to evolve to interventional studies with vitamin D supplementation to confirm that vitamin D has a true therapeutic role for treating disease activity in IBD.
Evaluation of a 12-week targeted vitamin D supplementation regimen in patients with active inflammatory bowel disease. [2022]Vitamin D at serum 25(OH)D concentrations above 100 nmol/L is associated with disease remission in patients with IBD, suggesting targeted dosing might be anti-inflammatory. This study aimed to assess the effectiveness, safety and predictors of a 12-week regimen of vitamin D supplementation to achieve such a target in patients with active disease.
Impact of High-Dose Vitamin D3 Supplementation in Patients with Crohn's Disease in Remission: A Pilot Randomized Double-Blind Controlled Study. [2022]To assess the tolerability and efficacy of high-dose vitamin D3 in patients with Crohn's disease (CD).
Relationships between vitamin D, parathyroid hormone and bone mineral density in inflammatory bowel disease. [2022]To explore the relationships between vitamin D intake, serum parathyroid hormone (PTH) and 25-hydroxyvitamin D (250HD) concentrations, and bone mineral density (BMD) in inflammatory bowel disease (IBD).
Effect of vitamin D3 supplementation on TNF-α serum level and disease activity index in Iranian IBD patients. [2022]The aim of the study was to assess the effectiveness of vitamin D3 [1, 25(OH)2D3] treatment in IBD with regard to tumor necrosis factor-alpha (TNF-α) serum level and clinical disease activity index (CDAI).