Overview

Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency

Status:
Not yet recruiting
Trial end date:
2021-03-01
Target enrollment:
0
Participant gender:
All
Summary
Aims:Prospectively observe the effects of Caltrate supplementation on the chronic course of Crohn's disease patients, analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc.Provide a certain theoretical basis for "precision treatment" for CD patients in the future. Design：It is a prospective cohort study. Investigators include a total of 60 participants with CD according to the inclusion and exclusion criteria, and divide them into two groups to assess their initial disease activity and detect related indicators. At the same time，Investigators detect the Vitamin D Gene gene polymorphisms in all participants.One group is given Caltrate 0.6g per day orally, and the control group do not intervene. After 12 months, re-evaluate the disease activity and retest the relevant indicators, and use statistical methods to analyze whether Caltrate supplementation treatment can increase the serum 25 (OH) D level of CD participants, improve the condition of CD participants,relationship with Vitamin D Gene Polymorphism，and analyze the effect of Caltrate on participants with CD is affected by factors such as disease site, disease activity, and treatment.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Second Affiliated Hospital of Wenzhou Medical University
Treatments:
Calcium Carbonate
Ergocalciferols
Vitamin D
Vitamins
Criteria
Inclusion Criteria:

- Clearly diagnosed patients with CD

- Vitamin D deficiency (<= 20ng / ml)

Exclusion Criteria:

- Pregnancy, lactation

- Liver and kidney insufficiency

- Co-morbid with other autoimmune diseases

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

- Vitamin D level is normal or high