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

Crohn Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04606017
• Other study ID #: SAHoWMU-CR2020-01-213
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2021
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• moderate-to-severe CD

• Treated with Infliximab

• bio-naïve at the time of diagnosis

Exclusion Criteria:

• had recent supplementation of vitD3

• had prior or concomitant use of other biologic agent, glucocorticoid and/or immunomodulators at the time of enrollment

• 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

Related Conditions & MeSH terms

• Crohn Disease
• Vitamin D Deficiency
• Vitamin D Supplement

Intervention

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.

Locations

Country	Name	City	State
China	SAHWenzhouMU	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25 (OH) D level	Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.	54 weeks
Primary	disease activity	CDAI evaluation	54 weeks
Secondary	the metabolism of calcium and phosphorus	serum levels calcium and phosphorus	54 weeks
Secondary	the expression profiles of Th-cell-related cytokines	Serum levels of IL-2, IL-4, IL-6, IL-10, TNF-a and IFN-?	54 weeks