Clinical Efficacy, Crohn's Disease, Ustekinumab, Vitamin D Supplementation
Conditions
Brief summary
It is uncertain whether vitD3 supplementation is beneficial for the remission of Crohn's disease (CD). The effects of vitD3 supplements on the efficacy of ustekinumab in Chinese CD patients were retrospectively analyzed. Methods: Patients with moderate to severe CD were recorded. These patients were initially treated with UST. VitD3 supplementation was defined as 400IU/d vitD3 supplementation during the first infusion of UST and continued throughout the follow-up period. Disease activity was assessed using Harvey Bradshaw Index.
Interventions
None listed
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Inclusion criteria
* moderate-to-severe CD * Treated with Ustekinumab
Exclusion criteria
* had recent supplementation of vitD3 * pregnant * had cognitive/developmental disorders that affected their ability to complete the study procedures * had medical illness or therapies potentially affecting bone, nutrition or growth status * unknown or untested baseline serum 25(OH)D level
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum 25 (OH) D level | 24 weeks | Vitamin D deficiency is defined as serum 25 (OH) D level\<20 μ g/L |
| disease activity | 24weeks | Harvey Bradshaw Index，mild: 0 to 8, moderate: 9 to 16, severe: 17 to 25 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum 25 (OH) D level | 8 weeks | Vitamin D deficiency is defined as serum 25 (OH) D level\<20 μ g/L |
Countries
China
Outcome results
None listed