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

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ClinicalTrials.gov Identifier: NCT04606017
Recruitment Status : Completed
First Posted : October 28, 2020
Last Update Posted : April 28, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

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.

Condition or disease Intervention/treatment
Crohn Disease Vitamin D Deficiency Vitamin D Supplement Drug: Caltrate Pill

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Study Type : Observational
Actual Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Influence of Vitamin D3 Supplementation on Infliximab Efficacy in Chinese Patients With Crohn's Disease: A Retrospective Cohort Study
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chinese
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606017


Locations
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China, Zhejiang
SAHWenzhouMU
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
Investigators
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Study Director: Xia sheng long long, Master Second Affiliated Hospital of Wenzhou Medical University
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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04606017    
Other Study ID Numbers: SAHoWMU-CR2020-01-213
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Vitamin D Deficiency
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium Carbonate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents