This is a randomized, double-blind placebo-controlled trial of high dose vitamin D3 at 10,000 International Units (IU) daily compared to low dose at 1000 IU daily in patients with Crohn's disease in remission.
In patients with Crohn's disease in remission, the investigators hypothesized higher doses of vitamin D would more effectively improve 25-hydroxy(OH)-vitamin D levels and would be tolerated well without side effects of hypercalcemia. The investigators also wanted to explore whether higher doses could reduce the clinical relapse rate of patients with Crohn's disease in remission, and if higher doses of vitamin D3 could improve depression and anxiety symptoms. In order to determine if there is benefit from high-dose vitamin D3, the investigators designed a pilot randomized double-blind controlled trial comparing doses of oral vitamin D3 at 10,000 IU daily to 1000 IU daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Improvement in 25-OH vitamin D level
Time frame: One year
Clinical Remission (defined as Harvey-Bradshaw index <=4)
Number of patients who maintain clinical remission
Time frame: One year
Improvement in Depression scores (measured by Hospital Anxiety and Depression Scale (HADS))
Number of patients who achieve significant improvement in HADS (reduction of 2 or more)
Time frame: One year
Improvement in C-reactive protein
Comparison of C-reactive protein levels in high and low dose vitamin D3 groups
Time frame: One year
Adverse events
Number of patients with treatment-related adverse events, including death, hypercalcemia, and hospitalization, as well as minor adverse events
Time frame: One year
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