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

Completed

• Conditions: Crohn Disease; Vitamin D Deficiency; Vitamin D Supplement
• Interventions: Drug: Caltrate Pill

• Registration Number: NCT04606017
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-01
• Study First Submitted: 2020-10-25
• Study First Submitted QC: 2020-10-25
• Study First Posted: 2020-10-28
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-25
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vitamain D	Caltrate Pill	This group of patients were supplemented with 125IU/d Vitamin D

Primary Outcome Measures

Name	Time	Method
Serum 25 (OH) D level	54 weeks	Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.
disease activity	54 weeks	CDAI evaluation

Secondary Outcome Measures

Name	Time	Method
the metabolism of calcium and phosphorus	54 weeks	serum levels calcium and phosphorus
the expression profiles of Th-cell-related cytokines	54 weeks	Serum levels of IL-2, IL-4, IL-6, IL-10, TNF-α and IFN-γ

Trial Locations

Locations (1)

SAHWenzhouMU; 🇨🇳 Wenzhou, Zhejiang, China