Crohn's Disease (CD), Ulcerative Colitis (UC)
Conditions
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.
Interventions
DIETARY_SUPPLEMENTVitamin 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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| vitamin D3 supplementation in IBD patients with hypovitaminosis D. | 90 days after patient taking the Vitamin D3 supplement daily | To determine the appropriate dose of vitamin D3 supplementation in IBD patients with hypovitaminosis D. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vitamin D3 supplementation on disease activity and quality of life | 90 days after patient taking the Vitamin D3 supplement daily | To assess the effect of vitamin D3 supplementation on IBD disease activity and quality of life in patients with IBD and hypovitaminosis D. |
Countries
United States
Outcome results
None listed