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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Crohn Disease; Vitamin D Supplement
• Intervention / Treatment: Drug: Caltrate Pill

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • SAHWenzhouMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vitamain D; This group of patients were supplemented with 125IU/d Vitamin D	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.
Control; The other group did not receive the supplementation of 125IU/d Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
disease activity	CDAI evaluation	54 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Investigators: Study Director: Xia sheng long long, Master, Second Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

General Publications

• Xia SL, Min QJ, Shao XX, Lin DP, Ma GL, Wu H, Cao SG, Jiang Y. Influence of Vitamin D3 Supplementation on Infliximab Effectiveness in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study. Front Nutr. 2021 Oct 22;8:739285. doi: 10.3389/fnut.2021.739285. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: October 25, 2020
• First Submitted That Met QC Criteria: October 25, 2020
• First Posted (Actual): October 28, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 25, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Inflammatory Bowel Diseases; Vitamin D Deficiency; Crohn Disease; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Calcium Carbonate
• Other Study ID Numbers: SAHoWMU-CR2020-01-213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No