Vitamin D Repletion and Maintenance in IBD: How Much and How Often

Study Overview
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Brief Summary
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Inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), are chronic relapsing inflammatory conditions of the gastrointestinal tract. IBD is thought to result from a complex interaction between genetic, immune, microbial and environmental factors. There is emerging data suggesting Vitamin D may not only play a role in bone health but may also be involved in gut health as well. While there are guidelines regarding the recommending doses of Vitamin D for supplementation and maintenance in bone health, these strategies are unknown in those with inflammatory bowel disease. The investigators seek to determine a dosing strategy for this population using doses within the recommended guidelines for bone health.

Detailed Description
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Inflammatory bowel disease (IBD), which includes ulcerative colitis (UC) and Crohn's disease (CD), are chronic relapsing inflammatory conditions of the gastrointestinal tract. IBD is thought to result from a complex interaction between genetic, immune, microbial and environmental factors. The role of vitamin D in bone health and calcium homeostasis is well documented. However, emerging data suggests that vitamin D may also regulate immune responses, which may play a role in the pathogenesis and disease activity of IBD. The investigators seek to identify CD or UC patients with mild disease or in clinical remission who have vitamin D levels <30 ng/ml and not on any type of vitamin repletion therapy. The investigators will randomize the participants into one of four arms: (1) Oral 50,000 vitamin D IU every week for 12 weeks (2) Oral 50,000 vitamin D weekly for 12 weeks than oral 800 vitamin D IU/d (3) Oral 50,000 vitamin D IU weekly for 12 weeks then 5,000 vitamin D IU/d (4) Oral 5,000 vitamin D IU/d and check vitamin D levels and inflammatory markers as part of standard of care follow- up every 3 months for nine months. Every participant will receive dietary counseling throughout the study duration. Our aim is to identify an optimal dosing strategy for repletion and maintenance of vitamin D levels in the subset of IBD patients. Based on clinical experience, doses higher than the recommended doses for bone health are needed to achieve and maintain optimal levels of Vitamin D in IBD patients, even patients are in remission or do not have small bowel (malabsorption) involvement.

Official Title
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A Vitamin D Dosing Strategy for Adequate Repletion and Maintenance in IBD Patients With Minimal Disease Activity

Conditions
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Inflammatory Bowel Diseases, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Crohn's disease or Ulcerative colitis In clinical remission or with mild disease activity as determined by the Harvey Bradshaw Index (CD) ≤7 or Ulcerative Colitis disease activity index ≤6. 25(OH)D level <30 ng/ml within three months of study enrollment Provided verbal consent 18 years of age or older Exclusion Criteria: Unwilling to provide consent or lack capacity Moderate to severe disease activity (Harvey Bradshaw index >7 or UCDAI >6) Current pregnancy or attempting to conceive Known coexisting hyperparathyroidism Already on vitamin D supplementation, calcium supplementation or a multivitamin BMI >30 kg/m² History of kidney stones Subjects <18 years of age - pediatric population with different recommended dosing than adults (10). Non-english speakers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to one of four treatment arms for the duration of the study. Labs will be checked every 3 months as part of standard of care to help delineate the best strategy for repletion and maintenance of Vitamin D levels throughout the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Arm # 1<br>50,000 IU oral vitamin D2 per week for 12 weeks + Dietary counseling | Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)<br>* To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.<br>|
| Active Comparator: Treatment Arm # 2<br>50,000 IU oral vitamin D2 per week x 12 weeks then 800 IU/day oral vitamin D3 for 6 months + Dietary counseling | Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)<br>* To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.<br>|
| Active Comparator: Treatment Arm # 3<br>50,000 IU oral vitamin D2 per week x 12 weeks then 5,000 IU/day oral vitamin D3 for 6 months+ Dietary counseling | Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)<br>* To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.<br>|
| Active Comparator: Treatment Arm # 4<br>5,000 IU oral daily vitamin D3 for 9 months + Dietary counseling | Dietary Supplement: Vitamin D (ergocalciferol and/ or cholecalciferol)<br>* To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels after completion of repletion dosing |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D levels on maintenance dosing |  | 9 months |