Trials / Completed
CompletedNCT01877577
Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D
Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- University of California, San Francisco · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Vitamin D3 | 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. |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2013-07-01
- Completion
- 2013-09-01
- First posted
- 2013-06-13
- Last updated
- 2014-07-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01877577. Inclusion in this directory is not an endorsement.