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

• ClinicalTrials.gov Identifier: NCT04276636
• Recruitment Status: Unknown
• First Posted: February 19, 2020
• Last Update Posted: October 14, 2020
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Information provided by (Responsible Party): Second Affiliated Hospital of Wenzhou Medical University

Tracking Information

• First Submitted Date: February 17, 2020
• First Posted Date: February 19, 2020
• Last Update Posted Date: October 14, 2020
• Estimated Study Start Date: October 2020
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 18, 2020)

Serum 25 (OH) D level [ Time Frame: 1year ]

Because serum 25 (OH) D levels are relatively stable, they are considered the most reliable indicator of vitamin D status.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 18, 2020)

• White blood cell count [ Time Frame: 1year ]
  White blood cell count can be used to reflect the degree of inflammation in the body
• erythrocyte sedimentation rate [ Time Frame: 1year ]
  ESR can be used to reflect the degree of inflammation in the body.
• C-reactive protein. [ Time Frame: 1year ]
  C-reactive protein can be used to reflect the degree of inflammation in the human body

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

Brief 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Crohn's Disease
• Vitamin D Deficiency
• Vitamin D Supplement

Intervention

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.

Study Arms

• Experimental: Caltrate
  This group of patients are going to supplemented with Caltrate 0.6 g / d orally.
  Intervention: Drug: Caltrate Pill
• No Intervention: Control
  The other group do not interfere.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 18, 2020): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2021
• Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT04276636
• Other Study ID Numbers: SAHoWMU-CR2020-01-102
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Data sets will be made available on relevant requests and in accordance with journal guidelines when publishing results from this study.

• Current Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Second Affiliated Hospital of Wenzhou Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Xia Xia long, Master; Second Affiliated Hospital of Wenzhou Medical University

• PRS Account: Second Affiliated Hospital of Wenzhou Medical University
• Verification Date: October 2020