Clinical trial NCT01877577: Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D
Official title: Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease (CD)
Ulcerative Colitis (UC)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis)
* 18 years of age or older
* 25(OH)D levels \<30ng/ml
* willing to give informed written consent

Exclusion Criteria:

* Age \< 18 years
* Women who are pregnant or planning to become pregnant
* Patients already taking vitamin D3 ≥2,000 IU/daily prior to study enrollment

Primary outcomes:
measure: vitamin D3 supplementation in IBD patients with hypovitaminosis D.
timeFrame: 90 days after patient taking the Vitamin D3 supplement daily
Secondary outcomes:
measure: vitamin D3 supplementation on disease activity and quality of life
timeFrame: 90 days after patient taking the Vitamin D3 supplement daily
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center, Ambulatory Care Center
state: California
Study officials:
affiliation: Assistant Clinical Professor, UCSF
name: David Limsui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.