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

Second Affiliated Hospital of Wenzhou Medical University

Status

Completed

Conditions

Vitamin D Deficiency

Vitamin D Supplement

Crohn Disease

Treatments

Drug: Caltrate Pill

Study type

Observational

Funder types

Other

Identifiers

NCT04606017

SAHoWMU-CR2020-01-213

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No 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