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This study aims to evaluate the effect of vitamin D3 supplementation on disease activity and quality of life in IBD patients deficient in vitamin D, and also help determine the optimal dose of vitamin D3 for them.
Hypothesis: Supplementation of vitamin D3 in IBD patients with hypovitaminosis D can improve their quality of life and decrease IBD activity.
The incidence of hypovitaminosis D has been reported to be as high as 75% in patients with IBD. However, it is unclear whether low vitamin D levels contribute to the pathogenesis of IBD or are a consequence of IBD. Recent animal data studies suggest that maintenance of the epithelial barrier integrity in the large intestine by vitamin D is important in preventing IBD.
However, more evidence is required to determine the effect of vitamin D3 supplementation in patients with IBD. Furthermore, there is no clear consensus regarding the appropriate dose of vitamin D supplementation in IBD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2000 I/U Vitamin D3 | Active Comparator | 2000 I/U Vitamin D3 Daily |
|
| 4000 I/U Vitamin D3 | Active Comparator | 4000 I/U Vitamin D3 Daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary Supplement | Study patients who took 2,000 IU daily of vitamin D3 will be compared to those who took 4,000 IU daily to determine the different effects of vitamin D3 dose on quality of life, disease activity, and the laboratory tests in this study. |
| Measure | Description | Time Frame |
|---|---|---|
| vitamin D3 supplementation in IBD patients with hypovitaminosis D. | To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D. | 90 days after patient taking the Vitamin D3 supplement daily |
| Measure | Description | Time Frame |
|---|---|---|
| vitamin D3 supplementation on disease activity and quality of life | To assess the effect of vitamin D3 supplementation on IBD disease activity and quality of life in patients with IBD and hypovitaminosis D. | 90 days after patient taking the Vitamin D3 supplement daily |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Limsui, MD | Assistant Clinical Professor, UCSF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Regional Medical Center, Ambulatory Care Center | Fresno | California | 93721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21677747 | Background | Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209. | |
| 21527593 | Background | Ulitsky A, Ananthakrishnan AN, Naik A, Skaros S, Zadvornova Y, Binion DG, Issa M. Vitamin D deficiency in patients with inflammatory bowel disease: association with disease activity and quality of life. JPEN J Parenter Enteral Nutr. 2011 May;35(3):308-16. doi: 10.1177/0148607110381267. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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|
| 17962355 | Background | Kong J, Zhang Z, Musch MW, Ning G, Sun J, Hart J, Bissonnette M, Li YC. Novel role of the vitamin D receptor in maintaining the integrity of the intestinal mucosal barrier. Am J Physiol Gastrointest Liver Physiol. 2008 Jan;294(1):G208-16. doi: 10.1152/ajpgi.00398.2007. Epub 2007 Oct 25. |
| 21118827 | Background | Ross AC, Manson JE, Abrams SA, Aloia JF, Brannon PM, Clinton SK, Durazo-Arvizu RA, Gallagher JC, Gallo RL, Jones G, Kovacs CS, Mayne ST, Rosen CJ, Shapses SA. The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know. J Clin Endocrinol Metab. 2011 Jan;96(1):53-8. doi: 10.1210/jc.2010-2704. Epub 2010 Nov 29. |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |