Effect of Vitamin D Supplementation on the Efficacy of Ustekinumab in the Treatment of Crohn's Disease

Second Affiliated Hospital of Wenzhou Medical University

Status: Completed

Conditions: Ustekinumab; Clinical Efficacy; Crohn's Disease; Vitamin D Supplementation

Study type: Observational

Funder types: Other

Identifiers

NCT05867784

SAHoWMU-CR2023-01-203

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

supplementary group

Description:

take vitamin D supplementation (400 IU/day) during VDZ treatment

non-supplementary group

Description:

not take vitamin D supplementation (400 IU/day) during VDZ treatment