Crohn's Disease Clinical Trial
Official title:
Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency，a Prospective Cohort Study
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.
1. The research can be started only after approval by the Medical Ethics Committee of the
Second Affiliated Hospital of Wenzhou Medical University.
2. According to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease"
formulated by the Beijing Conference in 2018 as a standard, patients with clear
diagnosis of CD are collected. Exclusion criteria included pregnancy, breastfeeding,
liver and kidney dysfunction, concurrent autoimmune diseases, and use of antiepileptic
drugs or drugs metabolized by liver cytochrome P450 enzymes.
3. Assess disease activity of CD participants based on the "Simplified Crohn's disease
Activity Score".
4. General information about participants with CD is collected.
5. Detection of VDR gene polymorphisms using Snapshot technology.
6. Serum C-reactive protein, erythrocyte sedimentation rate, white blood cells, albumin,
creatinine, alanine aminotransferase, calcium and phosphorus levels are measured.
7. The level of serum 25 (OH) D of participants is detected.
8. Develop a treatment plan for participants.
9. Participants are divided into two groups, one group is given oral Caltrate 0.6g / d, and
the other group did not intervene.
10. The above serum indicators are re-measured in the 12th month, and the condition of CD
participants is also evaluated.
11. Follow-up for 12 months. By comparing the above indicators, observe that in the Han
population:
1. Can Caltrate supplementation increase serum 25 (OH) D levels in patients with CD?
2. Can Caltrate supplementation improve the condition of patients with CD?
3. whether vitamin D gene polymorphisms affect the efficacy of Caltrate
supplementation therapy?
4. Analyze whether the effect of Caltrate on CD patients is affected by factors such
as disease site, disease activity, treatment, etc ..
12. Through statistical analysis, comprehensive analysis of the effectiveness and safety of
Caltrate supplementation in Han patients with CD, and its relationship with vitamin D
gene polymorphisms, providing a theoretical basis for further "precise treatment"
intervention in inflammatory bowel disease.
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