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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT04606017
Date of registration: 25/10/2020
Prospective Registration: No
Primary sponsor: Second Affiliated Hospital of Wenzhou Medical University
Public title: Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response in Patients With Crohn's Disease
Scientific title: Effect of Vitamin D Combined With Calcium Supplementation on Infliximab Response
Date of first enrolment: January 1, 2019
Target sample size: 70
Recruitment status: Completed
Study type:  Observational
Study design:   
Countries of recruitment
Name:     Xia sheng long long, Master
Affiliation:  Second Affiliated Hospital of Wenzhou Medical University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Clearly newly diagnosed patients with CD

- Treated with Infliximab

- Vitamin D level was less than 30ng/ml

Exclusion Criteria:

- Pregnancy, lactation

- Liver and kidney insufficiency

- Co-morbid with other autoimmune diseases

- Used antiepileptic drugs or drugs metabolized by liver cytochrome P450 enzymes

- Vitamin D level was normal or high

Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Vitamin D Deficiency
Vitamin D Supplement
Drug: Caltrate Pill
Primary Outcome(s)
C-reactive protein [Time Frame: 54 weeks]
Erythrocyte sedimentation rate [Time Frame: 54 weeks]
Serum 25 (OH) D level [Time Frame: 54 weeks]
White blood cell count [Time Frame: 54 weeks]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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