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

NCT04606017 | Completed

• 1 other identifier: SAHoWMU-CR2020-01-213
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Vitamin D Deficiency; Vitamin D Supplement

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• the metabolism of calcium and phosphorus

  54 weeks

• the expression profiles of Th-cell-related cytokines

  54 weeks

Study Arms (2)

Vitamain D

This group of patients were supplemented with 125IU/d Vitamin D

Drug: Caltrate Pill

Control

The other group did not receive the supplementation of 125IU/d Vitamin D

Interventions

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.

Vitamain D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese

You may qualify if:

• moderate-to-severe CD
• Treated with Infliximab
• bio-naïve at the time of diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

• 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.

  PMID: 34746207 DERIVED

MeSH Terms

Conditions

Crohn Disease; Vitamin D Deficiency

Interventions

Calcium Carbonate

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Minerals

Study Officials

• Xia sheng long long, Master

  Second Affiliated Hospital of Wenzhou Medical University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: October 28, 2020
• Study Start: January 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: June 1, 2020
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CN (1)