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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04606017

Enrollment

Registered

2020-10-28

Start date

2014-01-01

Completion date

2020-06-01

Last updated

2021-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease, Vitamin D Deficiency, Vitamin D Supplement

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.

Interventions

DRUGCaltrate 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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026