NCT04606017

Effect of Vitamin D Supplementation on Infliximab Response in Patients With Crohn's Disease

Influence of Vitamin D3 Supplementation on Infliximab Efficacy in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: It remains uncertain whether vitD3 supplementation is beneficial for remission of Crohn's disease (CD). The influence of vitD3 supplementation on Infliximab (IFX) efficacy was retrospectively analyzed in Chinese CD patients. Methods: Patients with moderate-to-severe CD, who were bio-naïve and prescribed with IFX treatment for at least 54 weeks were recorded. VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period. Disease activity was assessed using Harvey-Bradshaw Index (HBI). Serum cytokine profiles were quantitatively analyzed in a subset of all patients at baseline and 54-week after intervention.

Conditions

• Crohn Disease
• Vitamin D Deficiency
• Vitamin D Supplement

Interventions

Type	Name	Description
DRUG	Caltrate Pill	VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period.

Timeline

• Start date: 2014-01-01
• Primary completion: 2019-12-31
• Completion: 2020-06-01
• First posted: 2020-10-28
• Last updated: 2021-04-28

Locations

1 site across 1 country: China