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change in study design before recruitment began
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm # 1 | Active Comparator | 50,000 IU oral vitamin D2 per week for 12 weeks + Dietary counseling |
|
| Treatment Arm # 2 | Active Comparator | 50,000 IU oral vitamin D2 per week x 12 weeks then 800 IU/day oral vitamin D3 for 6 months + Dietary counseling |
|
| Treatment Arm # 3 | Active Comparator | 50,000 IU oral vitamin D2 per week x 12 weeks then 5,000 IU/day oral vitamin D3 for 6 months+ Dietary counseling |
|
| Treatment Arm # 4 | Active Comparator | 5,000 IU oral daily vitamin D3 for 9 months + Dietary counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D (ergocalciferol and/ or cholecalciferol) | Dietary Supplement | To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D levels after completion of repletion dosing | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vitamin D levels on maintenance dosing | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication compliance among participants | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17653185 | Background | Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005. | |
| 25732745 | Background | Ananthakrishnan AN. Epidemiology and risk factors for IBD. Nat Rev Gastroenterol Hepatol. 2015 Apr;12(4):205-17. doi: 10.1038/nrgastro.2015.34. Epub 2015 Mar 3. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D004872 | Ergocalciferols |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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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.
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| 22085500 | Background | Cantorna MT. Vitamin D, multiple sclerosis and inflammatory bowel disease. Arch Biochem Biophys. 2012 Jul 1;523(1):103-6. doi: 10.1016/j.abb.2011.11.001. Epub 2011 Nov 10. |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |