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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04276636
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Second Affiliated Hospital of Wenzhou Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Xia Xia long, Master
Principal Investigator Affiliation Second Affiliated Hospital of Wenzhou Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease, Vitamin D Deficiency, Vitamin D Supplement
Additional Details

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.

Arms & Interventions

Arms

Experimental: Caltrate

This group of patients are going to supplemented with Caltrate 0.6 g / d orally.

No Intervention: Control

The other group do not interfere.

Interventions

Drug: - Caltrate Pill

Vitamin D-deficient CD patients are divided into two groups, one group is given orally with Caltrate Pill 0.6 g / d, while the other group do not interfere.

Contact a Trial Team

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International Sites

SAHWenzhouMU, Wenzhou, Zhejiang, China

Status

Address

SAHWenzhouMU

Wenzhou, Zhejiang, 325000