Exploring the Effects of Caltrate Supplement on the Chronic Course of Crohn's Disease Patients With Vitamin D Deficiency
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn's Disease
- Vitamin D Deficiency
- Vitamin D Supplement
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
The research can be started only after approval by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University. According to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease" formulated by the Beijing Conference in 2018 as a standard, patients ...
The research can be started only after approval by the Medical Ethics Committee of the Second Affiliated Hospital of Wenzhou Medical University. 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. Assess disease activity of CD participants based on the "Simplified Crohn's disease Activity Score". General information about participants with CD is collected. Detection of VDR gene polymorphisms using Snapshot technology. Serum C-reactive protein, erythrocyte sedimentation rate, white blood cells, albumin, creatinine, alanine aminotransferase, calcium and phosphorus levels are measured. The level of serum 25 (OH) D of participants is detected. Develop a treatment plan for participants. Participants are divided into two groups, one group is given oral Caltrate 0.6g / d, and the other group did not intervene. The above serum indicators are re-measured in the 12th month, and the condition of CD participants is also evaluated. Follow-up for 12 months. By comparing the above indicators, observe that in the Han population: Can Caltrate supplementation increase serum 25 (OH) D levels in patients with CD? Can Caltrate supplementation improve the condition of patients with CD? whether vitamin D gene polymorphisms affect the efficacy of Caltrate supplementation therapy? Analyze whether the effect of Caltrate on CD patients is affected by factors such as disease site, disease activity, treatment, etc .. 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.
Tracking Information
- NCT #
- NCT04276636
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Xia Xia long, Master Second Affiliated Hospital of Wenzhou Medical University