Skip to main content
OpenTrials
Completed

NCT Number: NCT04606017

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Crohn Disease Avitaminosis Deficiency Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency Vitamin D Supplement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caltrate Pill

Drug

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.

Primary outcomes

  1. Serum 25 (OH) D level

    Time frame: 54 weeks

    Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.

  2. disease activity

    Time frame: 54 weeks

    CDAI evaluation

Secondary outcomes

  1. the metabolism of calcium and phosphorus

    Time frame: 54 weeks

    serum levels calcium and phosphorus

  2. the expression profiles of Th-cell-related cytokines

    Time frame: 54 weeks

    Serum levels of IL-2, IL-4, IL-6, IL-10, TNF-α and IFN-γ

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Oct 28, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.